Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER EIGHTEEN
Transitional and interim provisions
First sub-chapter
Transitional provisions arising out of the Law on the Reform of Drug Legislation
Section 99
1961 Drug Law
The 1961 Drug Law within the meaning of this Act is the Law on the Trade in Drugs of 16 May 1961 (Federal Law Gazette I p. 533) last amended by the law of 2 July 1975 (Federal Law Gazette I p. 1745).
Section 100
(1) Any authorisation which had been granted pursuant to Section 12 sub-section 1 or Section 19 sub-section 1 of the 1961 Drug Law and was still valid on 1 January 1978, shall continue to be valid to the previous extent as an authorisation within the meaning of Section 13 sub-section 1 sentence 1.
(2) Any authorisation which is considered as granted pursuant to Section 53 sub-section 1 or Section 56 of the 1961 Drug Law and was still valid on 1 January 1978, shall continue to be valid to the previous extent as an authorisation within the meaning of Section 13 sub-section 1 sentence 1.
(3) Where the manufacture of medicinal products did not require an authorisation pursuant to the 1961 Drug Law, but requires an authorisation pursuant to Section 13 sub-section 1 sentence 1, such an authorisation shall be deemed to be granted to any person who had been carrying out the activity of manufacturing medicinal products, with an authorisation to do the same, for a period of at least three years on 1 January 1978; however, only in so far as manufacture is restricted to such medicinal products as had been manufactured previously or medicinal products which are similar in composition.
Section 101
(no longer applicable)
Section 102
(1) Any person who exercises the function of Production Manager, with an authorisation to do so, on 1 January 1978 shall continue to exercise this function to the same extent as hitherto.
(2) Any person who, on 1 January 1978, is in possession of the expert knowledge pursuant to Section 14 sub-section 1 of the 1961 Drug Law and does not exercise the function of Production Manager, may exercise the function of Production Manager if evidence of two years of practical experience in the manufacture of medicinal products can be shown. If the practical experience was obtained prior to 10 June 1965, proof shall be submitted of an additional year of practical experience prior to the commencement of this person’s activity.
(3) Any person who had commenced university studies pursuant to Section 15 sub-section 1, prior to 10 June 1975 shall be deemed to have acquired expert knowledge as a Production Manager, if he/she completed his/her studies by 10 June 1985 and exercised a function pursuant to Section 15 sub-sections 1 and 3, for at least two years. This shall be without prejudice to the provisions contained in sub-section 2.
(4) Sub-sections 2 and 3 shall apply mutatis mutandis to any person seeking to work as a Quality Control Manager.
Section 102a
(no longer applicable)
Section 103
(1) In the case of medicinal products which, pursuant to Section 19a or Section 19d in conjunction with Section 19a of the 1961 Drug Law, are authorised for marketing on 1 January 1978 or which are deemed to have been granted a marketing authorisation on 1 January 1978 pursuant to Article 4 sub-section 1 of the Law on the Establishment of a Federal Agency for Sera and Vaccines of 7 July 1972 (Federal Law Gazette I, p. 1163), a marketing authorisation pursuant to Section 25 shall be deemed to be granted. Sections 28 to 31 shall apply mutatis mutandis to the marketing authorisation.
(2) (no longer applicable)
Section 104
(no longer applicable)
Section 105
(1) Finished medicinal products which are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and are on the market on 1 January 1978 are deemed to be authorised for marketing if they are on the market on 1 September 1976 or, by virtue of an application submitted by this date, are registered in the register for proprietary medicinal products pursuant to the 1961 Drug Law.
(2) Notification of finished medicinal products pursuant to sub-section 1 must be made to the competent higher federal authority indicating the designation of the active substances according to their nature and quantity as well as their therapeutic indications, within a period of six months from the 1 January 1978. In making a notification regarding a homeopathic medicinal product, the information bearing on the therapeutic indications may be omitted. A copy of the notification shall be sent to the competent authority indicating the stipulated information. The finished medicinal products may only be kept on the market if the deadline for notification is observed.
(3) The marketing authorisation for a medicinal product, notification of which has been submitted within the deadline pursuant to sub-section 2 shall expire by way of derogation from Section 31 sub-section 1 number 3, on 30 April 1990 unless an application for a prolongation of the marketing authorisation, or for registration, is submitted prior to the date of expiry, or unless the medicinal product is exempted from the need for a marketing authorisation or registration by ordinance. Section 31 sub-section 4 sentence 1 shall not apply to the marketing authorisation pursuant to sentence 1 if the renouncement pursuant to Section 31 sub-section 1 sentence 1 number 2 is submitted by 31 January 2001.
(3a) Until the first prolongation of the marketing authorisation, a modification pursuant to Section 29 sub-section 2a sentence 1 number 1, in the case of finished medicinal products pursuant to sub-section 1, in so far as it concerns the therapeutic indications, and number 3 shall only be admissible if it is necessary to correct the flaws, bearing on the efficacy or safety of the medicinal product, indicated to the applicant by the competent higher federal authority; furthermore, Section 29 sub-section 2a sentence 1 numbers 1, 2 and 5 shall not apply to finished medicinal products pursuant to sub-section 1, until the first prolongation of the marketing authorisation. By way of derogation from Section 29 sub-section 3, a finished medicinal product pursuant to sub-section 1, which has been manufactured using a manufacturing procedure described in the homeopathic section of the Pharmacopoeia, may be placed on the market up until the first prolongation of the marketing authorisation:
1. with a change in the composition of the medically active constituents in type and quantity, if the change consists only in the fact that one or several medically active constituents, contained up to that point in the medicinal product, are no longer present after the change or are present in lesser quantities,
2. with a change in the quantity of the medically active constituent and, within the hitherto existing area of application, with a change in indication if the medicinal product is adjusted as a whole to the results published pursuant to Section 25 sub-section 7 sentence 1, in the version in force before 17 August 1994,
3. (no longer applicable)
4. with a change in the quantity of the medically active constituents, in so far as it is a medicinal product with several active constituents the number of which has been reduced, or
5. with a change in the type or quantity of the medically active constituents without increasing their number within the same therapeutic indication and the same school of therapy if the medicinal product, as a whole, is adjusted to a result published pursuant to Section 25 sub-section 7 sentence 1, in the version in force before 17 August 1994 or to a medicinal product model submitted by the Federal Institute for Drugs and Medical Devices and the medicinal product does not become subject to prescription as a result of the adjustment;
a change shall only be admissible in so far as it is necessary for the purpose of correcting the flaw bearing on the efficacy or safety of the medicinal product indicated to the applicant by the competent higher federal authority. The pharmaceutical entrepreneur shall make notification of the change and in the event of a change in the composition, shall cause a clearly differentiating addition, which rules out any possibility of confusion with the previous name, to be made to the previous name of the medicinal product for a period of at least five years. Upon expiry of a period of six months following the notification, the pharmaceutical entrepreneur may place the medicinal product on the market henceforth only in its changed form. In the event that the competent higher federal authority has stipulated the use of a package leaflet with a standard wording for specific medicinal products, by imposition of a condition pursuant to Section 28 sub-section 2 number 3, the medicinal product may be placed on the market when changed pursuant to sentence 2 number 2, by way of derogation from Section 109 sub-section 2, only with a package leaflet pursuant to Section 11.
(4) In applying for a prolongation of the marketing authorisation, documents pursuant to Section 22 sub-section 1 numbers 1 to 6 shall be submitted in derogation of Section 31 sub-section 2. The competent higher federal authority shall determine, on a case by case basis, when the documents pursuant to Section 22 sub-section 1 numbers 7 to 15 sub-section 2 number 1 and sub-section 3a and, in the case of medicated pre-mixes, the documents pursuant to Section 23 sub-section 2 sentences 1 and 2, as well as the analytical expert opinion pursuant to Section 24 sub-section 1 are to be submitted. If requested by the competent authority, documents shall also be submitted providing evidence that the medicinal product’s medically active constituents possess sufficient bioavailability in so far as this is required according to the current state of scientific knowledge. An appraising expert opinion shall also be submitted. Section 22 sub-section 2 sentence 2 and sub-sections 4 to 7 and Section 23 sub-section 3 shall apply mutatis mutandis. The documents referred to in sentences 2 to 5 shall be submitted within a period of four months following the request by the competent higher federal authority.
(4a) In applying for a prolongation of the marketing authorisation pursuant to sub-section 3, documents pursuant to Section 22 sub-section 2 numbers 2 and 3, as well as the expert opinions pursuant to Section 24 sub-section 1 sentence 2 numbers 2 and 3 shall be submitted by 1 February 2001 in cases where these documents have not already been submitted by the applicant; Section 22 sub-section 3 shall apply mutatis mutandis. Sentence 1 shall not apply to medicinal products which have been manufactured using a manufacturing procedure described in the homeopathic section of the Pharmacopoeia. In the case of whole blood, plasma and blood cells of human origin, by way of derogation from sentence 1, the documents pursuant to Section 22 sub-section 2 number 2 and the expert opinion pursuant to Section 24 sub-section 1 sentence 2 number 2 shall not be required unless substances are contained therein which do not exist naturally in the human body. With the exception of the cases specified in Section 109a, the marketing authorisation shall expire if the documents stipulated in sentences 1 to 3 are not submitted on time.
(4b) In submitting documents pursuant to Section 22 sub-section 2 number 2, in the case of veterinary medicinal products which contain pharmacologically active substances which are listed in Table 1 of the Annex to Regulation (EU) No. 37/2010, reference may be made to documents submitted pursuant to the provisions contained in a legal instrument based on Article 13 of Regulation (EC) No. 470/2009, in so far as a veterinary medicinal product containing this pharmacologically active constituent has already been authorised for marketing in a Member State of the European Union and the prerequisites for referring to such documents pursuant to Section 24a have been met.
(4c) If the medicinal product pursuant to sub-section 3 has already been authorised for marketing in another Member State of the European Union or another State Party to the Agreement on the European Economic Area, in keeping with Directive 2001/83/EC or Directive 2001/82/EC, the prolongation of the marketing authorisation shall be granted if:
1. the medicinal product is on the market in the other Member State and
2. the applicant:
a) provides all of the information stipulated under Section 22 sub-section 6 and submits the necessary copies and
b) declares in writing that the documents submitted pursuant to sub-sections 4 and 4a match the marketing authorisation documents on the basis of which the authorisation was granted in the other Member States,
unless the prolongation of the marketing authorisation could constitute a danger for public health or, in the case of medicinal products intended for administration to animals, a danger to the health of human beings, animals or the environment.
(4d) In applying for registration, documents pursuant to Section 22 sub-section 1 numbers 1 to 4 shall be submitted along with the application in derogation of Section 38 sub-section 2. The documents pursuant to Section 22 sub-section 1 numbers 7 to 15 and sub-section 2 number 1, as well as the analytical expert opinion pursuant to Section 24 sub-section 1 shall be submitted to the competent higher federal authority if requested. Section 22 sub-sections 4 to 7, with the exception of the draft of the expert information, shall apply mutatis mutandis. The documents stipulated in sentences 2 and 3 shall be submitted within a period of two months following a request by the competent higher federal authority.
(4e) In deciding on an application for prolongation of a marketing authorisation or registration pursuant to sub-section 3 sentence 1, Section 25 sub-section 5 sentence 5 and Section 39 sub-section 1 sentence 2 shall apply mutatis mutandis.
(4f) The manufacturing authorisation pursuant to sub-section 1 shall be prolonged upon request pursuant to sub-section 3 sentence 1, for a period of five years if no reason for a refusal pursuant to Section 25 sub-section 2 exists; for additional prolongations, Section 31 shall apply. The particularities of a specific substance group or school of therapy (phytotherapy, homeopathy, and anthroposophy) shall be taken into consideration.
(4g) In the case of medicinal products which are blood preparations, Section 25 sub-section 8 shall be applied mutatis mutandis.
(5) In the case of flaws, the applicant shall correct the flaws within a reasonable deadline which may, however, not exceed twelve months following the notification of flaws; the correcting of flaws shall be recorded in writing. In the event that the flaws are not corrected within this deadline, the marketing authorisation shall be refused. After the decision has been taken to refuse the marketing authorisation, the submission of documents in order to correct flaws shall not be allowed. In all appropriate cases, the competent authority shall refrain from giving notice of flaws pursuant to sentence 1 first half-sentence and shall instead prolong the marketing authorisation on the basis of sub-section 5a sentences 1 and 2, with a proviso requiring the applicant to correct the flaws within a deadline which it shall set according to its best judgement.
(5a) The competent higher federal authority is empowered to impose conditions on the prolongation of the marketing authorisation pursuant to sub-section 3 sentence 1. Apart from ensuring the requirements stipulated in Section 28 sub-section 2, the contents of conditions may also be geared towards guaranteeing the requirements of quality, safety and efficacy, unless notice must be given of flaws pursuant to sub-section 5 or the prolongation of the marketing authorisation refused as a result of serious deficiencies in the pharmaceutical quality, efficacy or safety. Sentence 2 shall apply mutatis mutandis to document requirements pursuant to Section 23 sub-section 1 number 1. The notice regarding the prolongation shall state whether the condition imposed shall be met immediately or by a deadline to be specified by the competent higher federal authority. Notification shall be made to the competent higher federal authority of the fulfilment of the conditions, accompanied by a statutory declaration from an independent counter-expert confirming that the quality of the medicinal product corresponds to the current state of scientific knowledge. Section 25 sub-section 5 sentences 5, 6 and 8 as well as Section 30 sub-section 2 sentence 1 number 2, second alternative shall apply mutatis mutandis. Sentences 1 to 6 shall apply mutatis mutandis to the registration pursuant to sub-section 3 sentence 1.
(5b) No preliminary procedure pursuant to Section 68 of the Rules of the Administrative Court shall be held in the event of an appeal against the decision regarding the prolongation of the marketing authorisation pursuant to sub-section 3 sentence 1. Immediate execution shall be ordered pursuant to Section 80 sub-section 2 number 4 of the Rules of the Administrative Court, unless the execution would result in undue hardship for the pharmaceutical entrepreneur which is not justified by overriding public interest.
(5c) By way of derogation from sub-section 3 sentence 1, the marketing authorisation for a medicinal product for which a notification was made within the specified time pursuant to sub-section 2 and for which the pharmaceutical entrepreneur declared his/her intention to withdraw the application to prolong the marketing authorisation pursuant to sub-section 3 sentence 1 by 31 December 1999, shall expire on 1 February 2001 unless the procedure to prolong the marketing authorisation pursuant to sentence 2 is to be resumed. In cases where the pharmaceutical entrepreneur submitted the necessary documents on time in response to a request to that effect issued before 17 August 1994 pursuant to sub-section 4 sentence 2, or if the date of submission of documents for the medicinal product in question was subsequent to that date, or if the request for documents regarding the medicinal product in question was issued after said date, the procedure to prolong the marketing authorisation shall be resumed by the competent federal higher authority upon application by the entrepreneur; the application shall be submitted by 31 January 2001, accompanied by the documents specified in sub-section 4a sentence 1.
(5d) Sub-section 3 sentence 2 and sub-sections 3a to 5c shall apply mutatis mutandis to medicinal products for which an application for prolongation was submitted by 30 June 1991, pursuant to Section 4 sub-section 2 of the EC Transition Ordinance of 18 December 1990 (Federal Law Gazette I p. 2915) Annex 3 to Section 2 number 2, Chapter II numbers 1 and 2.
(6) (no longer applicable)
(7) Sub-sections 1 to 5d shall also apply to medicinal products intended for administration to animals that are not finished medicinal products in so far as they are required to have a marketing authorisation or to be registered and are on the market on 1 January 1978.
Section 105a
(1) (no longer applicable)
(2) (no longer applicable)
(3) In the case of finished medicinal products that are not subject to prescription pursuant to Section 49, the competent higher federal authority may, in the first instance, forego the examination of the expert information submitted and exempt the pharmaceutical entrepreneur from his/her duties pursuant to Section 11a, and the pharmaceutical consultant from his/her duty pursuant to Section 76 sub-section 1 sentence 1, until the standardized wording of the expert information for the medicinal products in question is stipulated by imposition of conditions pursuant to Section 28 sub-section 2 number 3.
(4) Sub-sections 1 to 3 shall not apply to medicinal products which are intended for administration to animals or which fall within the competence of the Paul Ehrlich Institute.
Section 105b
The right to the payment of fees and expenses which are to be levied pursuant to Section 33 sub-section 1, in conjunction with an ordinance issued pursuant to Section 33 sub-section 2 or Section 39 sub-section 3, for the prolongation of a marketing authorisation or for the registration of a finished medicinal product within the meaning of Section 105 sub-section 1 shall expire after a period of four years subsequent to informing the applicant of the final decision regarding the prolongation of the marketing authorisation or registration.
Section 106
(no longer applicable)
Section 107
(no longer applicable)
Section 108
(no longer applicable)
Section 108a
Any batch of serum, vaccine, test allergen, test serum or test antigens which was released at the time of the coming into effect of the accession pursuant to Section 16 of the Second Regulations Implementing the Drug Law of 1 December 1986 (Law Gazette I, No. 36 p. 483) shall be deemed to be released within the meaning of Section 32 sub-section 1 sentence 1, in the territory stipulated in Article 3 of the Unification Treaty. Section 32 sub-section 5 shall apply mutatis mutandis to the release.
Section 108b
(no longer applicable)
Section 109
(1) Finished medicinal products which are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and were on the market on 1 January 1978, shall be governed by Section 10 with the proviso that the marketing authorisation number stipulated in Section 10 sub-section 1 sentence 1 number 3 be replaced, where available, by the registration number recorded in the specialty register pursuant to the 1961 Drug Law with the abbreviation ‘Reg.-Nr.’. Sentence 1 shall be valid until the prolongation of the marketing authorisation or registration.
(2) The text for labels and package leaflets shall be submitted by 31 July 2001 at the latest. Until that date, medicinal products pursuant to sub-section 1 sentence 1 may be placed on the market by the pharmaceutical entrepreneur, thereafter by wholesalers and retailers with labels and package leaflets which are in keeping with the regulations in force up to the date specified in sentence 1.
(3) Finished medicinal products which are medicinal products within the meaning of Section 105 sub-section 1, and are released for trade outside of pharmacies pursuant to Section 44 sub-section 1 or sub-section 2 numbers 1 to 3 or Section 45 and fall under letters a to e may, without prejudice to the provisions contained in sub-sections 1 and 2, be placed on the market from 1 January 1992 by the pharmaceutical entrepreneur if they carry one or several of the following indications on their containers and, if used, on their outer packaging and package leaflet:
‘Traditionell angewendet (Traditionally used):
a) to strengthen and fortify,
b) to improve the state of health,
c) to support the functioning of the organs,
d) for prevention,
e) as a mild-action medicinal product.’
Sentence 1 shall not apply in cases where the therapeutic indications are restricted to the results published within the framework of a marketing authorisation pursuant to Section 25 sub-section 1, or a marketing authorisation pursuant to the version in force before 17 August 1994.
Section 109a
(1) In the case of medicinal products specified in Section 109 sub-section 3, as well as medicinal products that are not subject to a prescription and are not excluded from trade outside of pharmacies by virtue of an ordinance issued on the basis of Section 45 or 46, as a result of their components, their pharmaceutical forms or because they are chemical compounds with specific pharmacological effects or because such compounds have been added to them, the prolongation of the marketing authorisation can be granted pursuant to Section 105 sub-section 3 and, furthermore, pursuant to Section 31, pursuant to sub-sections 2 and 3.
(2) The requirements in respect of the necessary quality are deemed to be met when the documents pursuant to Section 22 sub-section 2 number 1, as well as the analytical expert opinions pursuant to Section 24 sub-section 1, have been submitted and the pharmaceutical entrepreneur has made a statutory declaration that the medicinal product has been tested in accordance with the general administrative regulation pursuant to Section 26 and displays the necessary pharmaceutical quality. The form and content of the statutory declaration shall be stipulated by the competent higher federal authority.
(3) The requirements in respect of the efficacy are deemed to be met when the medicinal product claims efficacy in therapeutic indications which are recognized in a list of the therapeutic indications for substances or combinations of substances compiled by the competent higher federal authority after a hearing by a commission set up by the Federal Ministry to which Section 25 sub-section 6 sentences 4 to 6 shall apply mutatis mutandis. These therapeutic indications shall be stipulated taking into account the peculiarities of the particular medicinal product and the experience which has been handed down and documented and shall be accompanied by the additional remark: ‘Traditionell angewendet’ (Traditionally used). Such therapeutic indications are: ‘to strengthen and fortify the …’, ‘to improve the state of health …’, ‘to support the functioning of the …’, ‘for prevention against …’, ‘as a mild-action medicinal product for use in …’. Therapeutic indications which would result in the medicinal product being excluded from trade outside of pharmacies may not be recognized.
(4) Sub-sections 1 to 3 shall apply only in cases where the documents pursuant to Section 105 sub-section 4a have not been submitted and the applicant declares in writing that he or she is pursuing a prolongation of the marketing authorisation pursuant to Section 105 sub-section 3, pursuant to sub-sections 2 and 3.
(4a) By way of derogation from sub-section 4, sub-sections 2 and 3 shall apply to medicinal products pursuant to sub-section 1, if the prolongation of the marketing authorisation would normally be refused owing to the fact that one of the published results substantiating the medicinal product’s efficacy pursuant to Section 25 sub-section 7 sentence 1 of the version in force prior to 17 August 1994, can no longer be recognised.
Section 110
In the case of medicinal products which are subject to a marketing authorisation pursuant to Section 21, or to registration pursuant to Section 38, and which are on the market on 1 January 1978, the competent higher federal authority can stipulate, by imposing conditions, the affixing of warnings in so far as they are necessary to prevent a direct or indirect health hazard to human beings or animals by the administration of the medicinal product.
Section 111
(no longer applicable)
Section 112
Any person who, on 1 January 1978, places medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, which are released for trade outside of pharmacies, on the market, on a retail basis outside of pharmacies, may continue to pursue this activity in so far as he or she was entitled to do so pursuant to the Act on the Exercise of Professions in the Retail Trade (Gesetz über die Berufsausübung im Einzelhandel) of 5 August 1957 (Federal Law Gazette I, p. 1121), amended by Article 150 sub-section 2 number 15 of the Law of 24 May 1968 (Federal Law Gazette I, p. 503).
Section 113
By way of derogation from Section 58 sub-section 1, medicinal products may be administered if it can be inferred from the labelling or accompanying documents that the medicinal products may continue to be placed on the market pursuant to Section 105 sub-section 1.
Section 114
(no longer applicable)
Section 115
Any person who exercises the function of a pharmaceutical consultant pursuant to Section 75 on 1 January 1978, shall not need to provide the proof of training stipulated therein.
Section 116
Physicians who are entitled, on 1 January 1978, under provisions contained in the legislation of the individual Land to manufacture and dispense medicinal products to persons being treated by them, may continue to pursue this activity to the same extent as hitherto. Section 78 shall be applicable.
Section 117
(no longer applicable)
Section 118
Section 84 shall not apply to damage caused by medicinal products which were dispensed prior to 1 January 1978.
Section 119
Finished medicinal products which are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and which are on the market in the territory referred to in Article 3 of the Unification Treaty, at the time when accession takes effect, may continue to be placed on the market by wholesalers and retailers without the package leaflet required under Section 11, in so far as they correspond to the provisions contained in the medical legislation of the German Democratic Republic in force before accession took effect. The competent higher federal authority may, by imposition of conditions, stipulate that warnings must be affixed, in so far as this is deemed necessary for the prevention of direct or indirect danger to human beings or animals as a result of the application of the medicinal product.
Section 120
In the case of a clinical trial that is being conducted within the territory specified in Article 3 of the Unification Treaty at the time when accession takes effect, the insurance policy required under Section 40 sub-section 1 number 8 shall be taken out.
Section 121
(no longer applicable)
Section 122
The obligation to notify pursuant to Section 67 shall not apply to undertakings, facilities and persons in the territory specified in Article 3 of the Unification Treaty who are already pursuing an activity within the meaning of that provision at the time when accession takes effect.
Section 123
A person shall also be deemed to possess the necessary expert knowledge as a pharmaceutical consultant pursuant to Section 75 sub-section 2 number 2, if he or she has successfully completed a course of studies as a pharmaceutical engineer, a pharmacy assistant or veterinary engineer in the territory specified in Article 3 of the Unification Treaty.
Section 124
Sections 84 to 94a shall not be applicable to medicinal products which were dispensed to consumers in the territory specified in Article 3 of the Unification Treaty before accession took effect.
Second sub-chapter
Section 125
Transitional provisions arising out of the First Act Amending the Drug Law
(1) After hearing the commissions pursuant to Section 25 sub-sections 6 and 7, the competent higher federal authority shall lay down, in the case of medicinal products which were authorised for marketing on 2 March 1983, the deadline by which the documents regarding the test method pursuant to Section 23 sub-section 2 sentence 3 are to be submitted.
(2) In the case of medicinal products for which a marketing authorisation was applied after 1 March 1983, and before 4 March 1998, the provisions contained in Section 23 shall apply with the proviso that the documents regarding the test methods do not have to be submitted prior to the deadline referred to in sub-section 1.
(3) In cases where a deadline for the submission of documents regarding the test method pursuant to sub-section 1 has been set, the marketing authorisation may be withdrawn if the documents are not submitted or if they fail to meet the requirements stipulated in Section 23 sub-section 2 sentence 3.
Section 126
In the case of medicinal products intended for administration to animals, and which are authorised for marketing in the territory specified in Article 3 of the Unification Treaty at the time when accession takes effect, Section 125 sub-sections 1 and 3 shall apply mutatis mutandis.
Third sub-chapter
Transitional provisions arising out of the Second Act Amending the Drug Law
Section 127
(1) Medicinal products which are on the market on 1 February 1987 and are subject to the labelling provisions contained in Section 10, must be placed on the market by the pharmaceutical entrepreneur pursuant to the provision contained in Section 10 sub-section 1 number 9 within a period of one year after the first prolongation of the marketing authorisation on 1 February 1987, or after the exemption from the marketing authorisation or, in the case of homeopathic medicinal products, five years after the 1 February 1987. Up to this point in time, medicinal products pursuant to sentence 1 may be placed on the market by the pharmaceutical entrepreneur, after this, they may continue to be placed on the market by wholesalers and retailers without indication of an expiry date if the medicinal product’s shelf-life is more than three years or, in the case of medicinal products governed by the provisions contained in Section 109, more than two years. The foregoing shall be without prejudice to the provisions contained in Section 109.
(2) Medicinal products which are on the market on 1 February 1987 and are subject to the labelling regulations of Section 10 sub-section 1a may be placed on the market until 31 December 1988 by the pharmaceutical entrepreneur and even after this deadline by wholesalers and retailers without the information stipulated in Section 10 sub-section 1a.
Section 128
(1) In the case of finished medicinal products which are on the market on 1 February 1987, the pharmaceutical entrepreneur shall submit the wording of the expert information to the competent higher federal authority along with the first application for the prolongation of the marketing authorisation or registration filed on 1 February 1987. Sentence 1 shall not apply in so far as the competent higher federal authority has exempted medicinal products that are not subject to prescription pursuant to Section 49, from the obligations contained in Section 11a, until further notice; in this case, the draft of the expert information is to be submitted upon request to the competent higher federal authority.
(2) In the cases described in sub-section 1 Section 11a, Section 47 sub-section 3 sentence 2 and Section 76 sub-section 1 shall apply from the date of the prolongation of the marketing authorisation or the registration or the stipulation of a specific expert information by means of Section 36 sub-section 1, or in the cases described in sub-section 1 sentence 2, six months after the decision of the competent higher federal authorities on the contents of the expert information. Finished medicinal products, the package leaflet of which fails to comply with the provisions contained in Section 11 sub-section 1, in the version of the Second Law Amending the Drug Law, may be placed on the market until this point in time.
Section 129
Section 11 sub-section 1a shall apply to medicinal products which are on the market on 1 February 1987 subject to the proviso that their package leaflet must be forwarded to the competent authority after the next prolongation of the authorisation or registration.
Section 130
Any person who is appointed as a private expert by 1 February 1987 to test samples pursuant to Section 65 sub-section 2 may continue to exercise this function to the same extent as hitherto.
Section 131
In respect of the obligation to submit or pass on expert information pursuant to Section 11a, Section 128 shall apply mutatis mutandis to medicinal products which are on the market in the territory stipulated in Article 3 of the Unification Treaty at the time of the coming into effect of accession.
Fourth sub-chapter
Transitional provisions arising out of the Fifth Act Amending the Drug Law
Section 132
(1) Medicinal products which are on the market on 17 August 1994 and are subject to the provisions contained in Sections 10 and 11, must be placed on the market by the pharmaceutical entrepreneur pursuant to the provisions contained in Sections 10 and 11 within a period of one year after the first prolongation of the marketing authorisation granted on 17 August 1994, or in so far as they are exempt from the need for a marketing authorisation, from the time stipulated in the ordinance pursuant to Section 36 or, in so far as homeopathic medicinal products are concerned, five years after 17 August 1994. Until such time, medicinal products pursuant to sentence 1 may be continue to be placed on the market by the pharmaceutical entrepreneur; thereafter, such medicinal products may continue to be placed on the market by wholesalers and retailers with labelling and package leaflets that comply with the provisions in force up to 17 August 1994. The foregoing shall be without prejudice to the provisions contained in Section 109.
(2) In the case of finished medicinal products which are on the market on 17 August 1994, the pharmaceutical entrepreneur shall submit the wording of the expert information in compliance with Section 11a of the current version of this Act to the competent higher federal authority along with the first application for the prolongation of the marketing authorisation filed on 17 August 1994. This shall be without prejudice to the provisions contained in Section 128 sub-section 1 sentence 2.
(2a) Marketing authorisations that are not in compliance with Section 16 shall be adapted to Section 16 by 17 August 1996. Sentence 1 shall apply to Section 72 mutatis mutandis.
(2b) Any person who exercises the function of Production Manager for the manufacture of blood preparations or as Quality Control Manager for the testing of blood preparations on 17 August 1994 and fulfils the prerequisites of Section 15 sub-section 3, as contained in the version in force up until 17 August 1994, may continue to exercise this function.
(3) (no longer applicable)
(4) Section 39 sub-section 2 numbers 4a and 5a shall not apply to medicinal products which were registered by 31 December 1993 or for which an application for registration was submitted by that date or for which a notification was made pursuant to Section 105 sub-section 2 and which were placed on the market pursuant to Section 38 sub-section 1 sentence 3, in the version valid before 11 September 1998. Furthermore, Section 39 sub-section 2 number 4a shall not apply to medicinal products pursuant to sentence 1 in respect of which a re-registration is being applied for because one or several constituent are to be removed or the degree of dilution of constituents is to be increased. Furthermore, Section 39 sub-section 2 numbers 4a and 5a shall not apply, in the case of decisions bearing on the registration or on its prolongation, to medicinal products which are identical, in the nature and quantity of their components as well as with regard to their pharmaceutical forms, with medicinal products specified in sentence 1. Section 21 sub-section 2a sentence 5 and Section 56a sub-section 2 sentence 5 shall also apply to medicinal products intended for administration to animals the degree of dilution of which is below the sixth decimal potency, in so far as they have been registered pursuant to sentence 1 or 2 or have been exempted from registration.
Fifth sub-chapter
Transitional provisions arising of the Seventh Act Amending the Drug Law
Section 133
The obligation to notify pursuant to Section 67 in conjunction with Section 69a shall apply to the enterprises, facilities and persons specified in Section 59c who were already exercising one of the functions provided for in Section 59c on 4 March 1998 with the proviso that the notification must be made at the latest by 1 April 1998.
Sixth sub-chapter
Transitional provisions arising out of the Transfusion Act
Section 134
Any person who, at the time of the entry into force of the Transfusion Act of 1 July 1998 (Federal Law Gazette I p. 1752), exercises the function of Production Manager in the manufacture of or as Quality Control Manager for the testing of blood preparations or sera from human blood and meets the requirements stipulated by Section 15 sub-section 3, in the version valid until that date, may continue to exercise that function. Any person who, at the time specified in sentence 1, exercises the function of pre-treating persons for the separation of blood stem cells or other blood components according to the technological and scientific state of the art, may continue to exercise this function.
Seventh sub-chapter
Transitional provisions arising out of the Eighth Act Amending the Drug Law
Section 135
(1) Medicinal products which are on the market on 11 September 1998 and are subject to the provisions contained in Sections 10 and 11, must be placed on the market one year after the first prolongation of the marketing authorisation on 11 September 1998 or, in so far as they are exempt from the marketing authorisation, on the date specified in the ordinance pursuant to Section 36 or, in so far as they are homeopathic medicinal products, on 1 October 2003, by the pharmaceutical entrepreneur pursuant to the provisions contained in Sections 10 and 11. Until this date, medicinal products pursuant to sentence 1 may be placed on the market by the pharmaceutical entrepreneur; after this date such medicinal products may continue to be placed on the market by wholesalers and retailers with labelling and package leaflets which are pursuant to the provisions in force up to 11 September 1998. The foregoing shall be without prejudice to the provisions contained in Section 109.
(2) Any person who on 11 September 1998 exercises the function of Production Manager or Quality Control Manager for the medicinal products or active substances named in Section 15 sub-section 3a and is authorised to do so, may continue to exercise this function to the same extent as hitherto. Until 1 October 2001, Section 15 sub-section 4 shall not apply to the practical activities involved in the manufacture of medicinal products and active substances pursuant to Section 15 sub-section 3a.
(3) Homeopathic medicinal products which are on the market on 11 September 1998, and for which an application for registration was submitted by 1 October 1999 may, by way of derogation from Section 38 sub-section 1 sentence 3, continue to be placed on the market until a decision has been taken on the application for registration as long as they are in compliance with the provisions in force until 11 September 1998.
(4) In the amended version, Section 41 number 6 shall not apply to declarations of consent which were made prior to 11 September 1998.
Eighth sub-chapter
Transitional provisions arising out of the Tenth Act Amending the Drug Law
Section 136
(1) In the case of medicinal products for which the prolongation applied for under Section 105 sub-section 3 sentence 1 has already been granted, the documents specified in Section 105 sub-section 4a sentence 1 shall be submitted, at the latest, with the application pursuant to Section 31 sub-section 1 number 3. In the case of such medicinal products, the marketing authorisation shall be prolonged if no reason for refusal pursuant to Section 25 sub-section 2 exists; Section 31 shall apply to further prolongations.
(1a) With regard to medicinal products pursuant to Section 105 sub-section 3 sentence 1 which are manufactured according to a procedure which is not described in the homeopathic section of the Pharmacopoeia, Section 105 sub-section 3 sentence 2 in the version in force up to 12 July 2000 shall apply until such time as a decision is made by the Commission pursuant to Section 55 sub-section 6, on the inclusion of this manufacturing procedure, in so far as an application has been submitted by 1 October 2000 regarding its inclusion in the homeopathic section of the Pharmacopoeia.
(2) In the case of medicinal products with respect to which the applicant has been notified prior to 12 July 2000 of flaws regarding their efficacy or safety, Section 105 sub-section 3a in the version in force up to 12 July 2000 shall apply.
(2a) Section 105 sub-section 3a sentence 2, in the version in force up to 12 July 2000, shall apply up to 31 January 2001 with the proviso that a notification of flaws is not necessary and a notification is admissible only if it is restricted to the fact that one or several medically active constituents contained up to that point in the medicinal product are no longer present after the notification.
(3) In the case of medicinal products which have been manufactured according to a manufacturing procedure described in the homeopathic section of the Pharmacopoeia, Section 105 sub-section 5c shall continue to apply in the version in force prior to 12 July 2000.
Ninth sub-chapter
Transitional provisions arising out of the Eleventh Act Amending the Drug Law
Section 137
By way of derogation from Section 13 sub-section 2, Section 47 sub-section 1 number 6, Section 56 sub-section 2 sentence 2 and sub-section 5 sentence 1, medicated feeding stuffs may continue to be manufactured, placed on the market and used until 31 December 2005 according to the regulations in force up to 1 November 2002. By way of derogation from Section 56 sub-section 2 sentence 1, medicated feeding stuffs may be manufactured using a maximum of three medicated pre-mixes, each of which are authorised for administration to the animal species in question, until 31 December 2005, if:
1. no authorised medicated pre-mix exists for the therapeutic indication in question,
2. in individual cases, the medicated feeding stuff does not contain more than two medicated pre-mixes containing antibiotics and
3. a homogeneous and stable distribution of the active constituents in the medicated feeding stuff is guaranteed.
By way of derogation from sentence 2 number 2, a medicated feeding stuff may contain only one medicated pre-mix containing antibiotics if the medicated pre-mix contains two or more substances with an antibiotic effect.
Tenth sub-chapter
Transitional provisions arising out of the Twelfth Act Amending the Drug Law
Section 138
(1) With regard to the manufacture and import of active substances of microbial origin, as well as other substances of human origin intended for the manufacture of medicinal products which are manufactured or imported into the territory governed by this Act, commercially or professionally, for the purpose of distribution to others, Sections 13, 72 and 72a in the version in force until 5 August 2004 shall be applicable until 1 September 2006, unless blood and blood components of human origin destined for the manufacture of medicinal products are concerned. If blood is withdrawn for the processing and multiplication of autologous somatic cells within the framework of tissue engineering for the purpose of tissue regeneration, and if an application has not yet been made for a manufacturing authorisation for this purpose, Section 13 shall not be applicable until 1 September 2006.
(2) Any person who, on 5 August 2004, is authorised to exercise the functions of a Production or Quality Control Manager may continue to exercise this function, in derogation of Section 15 sub-section 1.
(3) Sections 40 to 42, 96 number 10 and Section 97 sub-section 2 number 9, in the version in force until 6 August 2004, shall apply to clinical trials of medicinal products on human beings for which the documents required pursuant to Section 40 sub-section 1 sentence 2 in the version in force until 6 August 2004 were submitted to the ethics committee responsible for the chief investigator before 6 August 2004.
(4) Any person who is authorised to exercise the function of wholesaler on 6 August 2004 and submits an application pursuant to Section 52a sub-section 1, for an authorisation to conduct the wholesale distribution of medicinal products, by 1 December 2004, may, in derogation of Section 52a sub-section 1, continue to exercise this function until the decision has been taken with respect to the application; Section 52a sub-section 3 sentences 2 to 3 shall not apply.
(5) An official approval regarding the wholesale distribution of medicinal products intended for administration to animals, granted on the basis of the ordinance pursuant to Section 54 sub-section 2a shall constitute an authorisation within the meaning of Section 52a, for the wholesale distribution of medicinal products intended for administration to animals. The holder of the approval shall submit the corresponding documents and declarations pursuant to Section 52a sub-section 2, to the competent authority by 1 March 2005.
(6) Any person who was allowed to import substances other than active substances of human or animal origin or those manufactured using genetic engineering, without an import authorisation pursuant to Section 72, into the territory governed by this Act on 6 August 2004, may continue to pursue this activity until 1 September 2005.
(7) Medicinal products, which are authorised by the competent higher federal authority before 30 October 2005, may continue to be placed on the market by pharmaceutical entrepreneurs, in derogation of Section 10 sub-section 1b, up to the next prolongation but not after 30 October 2007. Medicinal products, which are placed on the market by pharmaceutical entrepreneurs pursuant to sentence 1 may continue to be placed on the market by wholesalers and retailers, in derogation of Section 10 sub-section 1b.
Eleventh sub-chapter
Transitional provisions arising out of the First Act Amending the Transfusion Act and the Regulations on Medicinal Products
Section 139
Any person who, on entry into force of Article 2 number 3 of the First Act amending the Transfusion Act and Regulations on Medicinal Products of 10 February 2005 (Federal Law Gazette I p. 234), carries out the functions of a Production or Control Manager for the testing of haematopoietic stem cell preparations from peripheral blood or from umbilical cord blood and fulfils the conditions contained in Section 15 sub-section 3 of the version in force at the time, may continue to exercise these functions.
Twelfth sub-chapter
Transitional provisions arising out of the Thirteenth Act Amending the Drug Law
Section 140
In derogation of Section 56a sub-section 2 and Section 73 sub-section 3, medicinal products not used in food-producing animals may be introduced into the purview of this Act, prescribed, dispensed or used up to 29 October 2005 pursuant to the regulations in force until 1 September 2005.
Thirteenth sub-chapter
Transitional provisions arising out of the Fourteenth Act Amending the Drug Law
Section 141
(1) Medicinal products that are on the market on 5 September 2005 and are subject to Sections 10 and 11, must be placed on the market by the pharmaceutical entrepreneur two years after the first prolongation of the marketing authorisation or registration following 6 September 2005 or, if they are exempted from the need for a marketing authorisation or registration at the time referred to in the ordinance pursuant to Section 36 or Section 39, or if they do not require a prolongation, on 1 January 2009 pursuant to Sections 10 and 11. Up to the relevant dates referred to in sentence 1, medicinal products may be placed on the market by pharmaceutical entrepreneurs and, after these dates, also by wholesale and retail distributors with labelling and a package leaflet complying with the provisions applicable up to 5 September 2005. The foregoing shall be without prejudice to the provisions contained in Section 109.
(2) In the case of finished products which are on the market on 5 September 2005, the pharmaceutical entrepreneur shall submit to the higher federal authority the wording of the expert information pursuant to Section 11a with the first application for prolongation submitted after 6 September 2005; if the medicinal products in question do not require prolongation, the requirement shall apply from 1 January 2009.
(3) A person who does not have the experience referred to in Section 15 but who is authorised on 5 September 2005 to engage in the activities of the qualified person described in Section 19, shall be regarded as a qualified person pursuant to Section 14.
(4) Finished medicinal products which are on the market on 5 September 2005 and which, pursuant to Section 4 sub-section 1, require a marketing authorisation pursuant to Section 21, for the first time after 6 September 2005, can still be placed on the market if a marketing authorisation application has been submitted by 1 September 2008.
(5) The periods relating to the protection of documents pursuant to Section 24b sub-sections 1, 4, 7 and 8 shall not apply to reference medicinal products for which the application for marketing authorisation was submitted before 30 October 2005; these medicinal products shall be subject to the protection deadlines referred to in Section 24a, in the version applicable until 5 September 2005, amounting to the period of ten years referred to in Section 24b sub-section 4.
(6) Medicinal products with a marketing authorisation that was prolonged before 1 January 2001, shall be subject to Section 31 sub-section 1 number 3, in the version applicable until 5 September 2005; Section 31 sub-section 1a shall apply to these medicinal products only if their marketing authorisation was prolonged after 6 September 2005. For marketing authorisations with a five-year validity which has expired by 1 July 2006, the deadline referred to in Section 31 sub-section 1 number 3 in the version applicable on 6 September 2005 shall continue to apply. For medicinal products with a marketing authorisation that was prolonged after 1 January 2001 and before 6 September 2005, the competent higher federal authority can stipulate the requirement of a further prolongation, if this is necessary to guarantee the safe placing on the market of the medicinal product. Marketing authorisation prolongation applications submitted before 6 September 2005 which, according to this sub-section, no longer require prolongation, shall be regarded as settled. Sentences 1 and 4 shall apply mutatis mutandis to registrations. Marketing authorisation prolongations or registrations of medicinal products which were considered authorised pursuant to Section 105 sub-section 1, shall be considered prolongations within the meaning of this sub-section. This shall be without prejudice to the provisions contained in Section 136 sub-section 1.
(7) The holder of the authorisation for a medicinal product which is authorised on 5 September 2005 but is not on the market at this time shall notify the competent higher federal authority immediately of the fact that the medicinal product will not be placed on the market.
(8) Section 33 in the version applicable until 5 September 2005, shall be applicable to protests which are lodged before 5 September 2005.
(9) Section 25 sub-section 9 and Section 34 sub-section 1a shall not be applicable to medicinal products for which the application for marketing authorisation was submitted before 6 September 2005.
(10) Medicinal products which were registered as homeopathic medicinal products by 6 September 2005 or for which an application for registration was submitted before 30 April 2005, shall still be subject to the provisions applicable up to that date. The same applies to medicinal products, which have been notified and placed on the market pursuant to Section 38 sub-section 1 sentence 3 of the version valid before 11 September 1998. Furthermore, Section 39 sub-section 2 number 5b shall not apply, in the case of decisions bearing on the registration or on its prolongation, to medicinal products which are identical, in the nature and quantity of their components as well as with regard to their pharmaceutical forms, with medicinal products specified in sentence 1.
(11) Section 48 sub-section 1 sentence 1 number 2 shall apply only from the date of entry into force of an ordinance pursuant to Section 48 sub-section 6 sentence 1 and at the latest on 1 January 2008. The Federal Ministry of Food and Agriculture shall publish the date referred to in sentence 1 in the Federal Law Gazette.
(12) Section 56a sub-section 2a shall apply only after the list referred to therein has been drawn up and published by the Federal Ministry of Food and Agriculture in the Federal Gazette or, if it is part of a directly applicable legal instrument of the European Community or of the European Union, after publication in the Official Journal of the European Union.
(13) In the case of medicinal products, which are on the market on 5 September 2005, for which the obligation to report pursuant to Section 63b sub-section 5 sentence 2 exists in the version valid up to 5 September 2005, Section 63b sub-section 5 sentence 3 shall apply to the next report to be submitted on 6 September 2005.
(14) The marketing authorisation of a traditional medicinal product that was extended pursuant to Section 105 in conjunction with Section 109a, shall expire on 30 April 2011 unless an application for marketing authorisation or registration pursuant to Section 39a was submitted before 1 January 2009. The marketing authorisation pursuant to Section 105, in conjunction with Section 109a shall moreover expire on 30 April 2011 after the decision on the application for a marketing authorisation or registration pursuant to Section 39a has been taken. After the decision, the medicinal product may continue to be placed on the market for a further twelve months in its present form.
Fourteenth sub-chapter
Section 142
Transitional provisions arising out of the Tissues Act
(1) Any person who, by 1 August 2007, possesses the expert knowledge required pursuant to Section 15 sub-section 3a, in the version in force up to that date, may continue to exercise the function of qualified person.
(2) Any person who had applied for an authorisation pursuant to Section 20b sub-section 1 or sub-section 2 or Section 20c sub-section 1, or a manufacturing authorisation pursuant to Section 13 sub-section 1 by 1 October 2007, or an authorisation pursuant to Section 21a sub-section 1 by 1 February 2008 or a marketing authorisation pursuant to Section 21 sub-section 1 by 30 September 2008 for tissues or tissue preparations, may continue to procure these tissues or tissue preparations, test them in laboratories, process, preserve, store or place them on the market until a decision is taken on the application.
(3) Any person who, on 1 August 2007, possesses a manufacturing authorisation pursuant to Section 13 sub-section 1, for tissues or tissue preparations within the meaning of Section 20b sub-section 1 or Section 20c sub-section 1, or a marketing authorisation pursuant to Section 21 sub-section 1 for tissue preparations within the meaning of Section 21a sub-section 1 shall not have to submit a new application pursuant to Section 20b sub-section 1, Section 20c sub-section 1 or Section 21a sub-section 1.
Section 142a
Transitional provision and grandfathering provision arising out of the Act Implementing Commission Directive (EU) 2015/566 and (EU) 2015/565 on the import and coding of human tissue and tissue products
(1) Section 72b, in the version in force up to and including 25 November 2016 shall apply to autologous blood for the manufacture of biotechnologically processed tissue products.
(2) Any person who, on 26 November 2016, possesses an authorisation pursuant to the version of Section 72 sub-section 1 in force up to and including 25 December 2016, to import haematopoietic stem cells and stem cell preparations derived from peripheral blood or umbilical cord blood, or an authorisation pursuant to the version of Section 72b sub-section 1 in force up to and including 25 December 2016, must meet the requirements of Section72 sub-sections 4 and 5, Section 72a sub-section 1 sentence 2 and sub-section 1e, Section72b sub-sections 1, 1a, 2 sentence 2, sub-sections 2a, 2c, 2d and of Section 72c, from 29. April 2017 onwards.
(3) The obligation to label haematopoietic stem cell preparations derived from peripheral blood or umbilical cord blood with the Single European Code, abbreviated ‘SEC’, pursuant to Section 10 sub-section 8a sentence 3 and the application to label tissue preparations with the Single European Code, abbreviated ‘SEC’, pursuant to Section 10 sub-section 8b sentence 1, are to be fulfilled from 29 April 2017.
Section 142b
Transitional provisions arising out of the Act Updating the Regulations governing Blood and Tissue Preparations and Amending Additional Provisions
(1) Any person who possesses an authorisation for advanced therapy medicinal products pursuant to Section 4b sub-section 3 in the version valid until 28 July 2017, must meet the requirements contained in Section 4b sub-section 3 sentences 3 and 4, from 29 July 2019 onwards.
(2) Any person who, on 29 July 2017, possesses an authorisation pursuant to Section 21a sub-section 1, must fulfil the requirements contained in Section 21a sub-sections 2 and 3, from 29 July 2019.
Fifteenth sub-chapter
Section 143
Transitional provisions arising out of the Act on improving measures against doping in sport
(repealed)
Sixteenth sub-chapter
Section 144
Transitional provisions arising out of the Act amending the regulations on medicinal products and other regulations
(1) Any person who manufactures the advanced therapy medicinal products specified in Section 4b sub-section 1 with permission on 23 July 2009 and applies for a manufacturing authorisation by 1 January 2010 may continue to manufacture these medicinal products until such time as a decision has been taken on the application.
(2) Any person who places the advanced therapy medicinal products specified in Section 4b sub-section 1 with the exception of biotechnologically processed tissue products on the market on 23 July 2009 with permission and applies for an authorisation pursuant to Section 4b sub-section 3 sentence 1 by 1 August 2010, may continue to place these medicinal products on the market until such time as a decision has been taken on the application.
(3) Any person who places biotechnologically processed tissue products within the meaning of Section 4b sub-section 1 with permission on the market on 23 July 2009 and applies for an authorisation pursuant to Section 4b sub-section 3 sentence 1 by 1 January 2011, may continue to place these medicinal products on the market until such time as a decision has been taken on the application.
(4) Any person who, on 23 July 2009, as the qualified person, possesses the expert knowledge pursuant to Section 15 sub-section 3a, in the version in force up to that point in time, may continue to exercise the function of qualified person.
(4a) Any person who, prior to 23 July 2009, as the qualified person, possessed the expert knowledge pursuant to Section 15 sub-sections 1 and 2 for medicinal products that, owing to the amendment of Section 4 sub-section 3 in the version in force from 23 July 2009, are classified as sera and require expert knowledge pursuant to Section 15 sub-section 3, was allowed to continue to perform his/her activities as the qualified person from 23 July 2009 to 26 October 2012. This also applies to any person who from 23 July 2009, as a qualified person, possessed the expert knowledge pursuant to Section 15 sub-sections 1 and 2 for these medicinal products.
(5) Any person who, on 23 July 2009, holds a manufacturing authorisation pursuant to Section 13 sub-section 1 for the procurement or the laboratory testing of autologous blood for the manufacture of biotechnologically processed tissue products does not require a new authorisation pursuant to Section 20b sub-section 1 or 2.
(6) The obligation to notify pursuant to Section 67 sub-section 5, shall exist from 1 January 2010 onwards for medicinal products which were already on the market on 23 July 2009.
(7) Any person who, on 23 July 2009, manufactures medicinal products pursuant to Section 4a sentence 1 number 3, in the version in force up to 23 July 2009, must notify the competent authority pursuant to Section 67 thereof by 1 February 2010. Any person who, on 23 July 2009, exercises a function pursuant to Section 4a sentence 1 number 3, in the version in force up to 23 July 2009, for which an authorisation pursuant to Sections 13, 20b or 20c is required and has applied for the authorisation by 1 August 2011, shall continue to exercise this function until such time as a decision has been taken on the application.
Seventeenth sub-chapter
Section 145
Transitional provisions arising out of the Act on the Reform of the Market for Medicinal Products
In the case of medicinal products which are already authorised when this Act enters into force, the pharmaceutical entrepreneur and the sponsor shall place the reports requested pursuant to Section 42b sub-sections 1 and 2 at the disposal of the competent higher federal authority for the first time at the latest 18 months subsequent to the entry into force of this Act. Sentence 1 shall apply to clinical trials for which Sections 40 to 42 in the version valid from 6 August 2004 applied.
Eighteenth sub-chapter
Transitional provision
Section 146
Transitional provisions arising out of the Second Act amending regulations on medicinal products and other regulations
(1) Medicinal products that are on the market on 26 October 2012 and are governed by the provisions contained in Section 10 sub-section 1 number 2, must be placed on the market by the pharmaceutical entrepreneur, pursuant to the provisions contained in Section 10 sub-section 1 number 2, two years after the first prolongation of the authorisation or registration after 26 October 2012, or, if they are exempt from the authorisation or registration or do not require a prolongation, on 26 October 2014. Up until the dates specified in each case pursuant to sentence 1, medicinal products may be placed on the market by the pharmaceutical entrepreneur; after these dates they may continue to be placed on the market by wholesalers and retailers bearing labelling that corresponds to the regulations in force up until 26 October 2012.
(2) In respect of the incorporation of the standard text pursuant to Section 11 sub-section 1 sentence 1 number 5, medicinal products that are on the market on 26 October 2012 and are governed by the provisions contained in Section 11, must be placed on the market by the pharmaceutical entrepreneur in keeping with the provisions contained in Section 11 two years after the first prolongation of the marketing authorisation or registration after the publication pursuant to Section 11 sub-section 1b regarding the standard text pursuant to Section 11 sub-section 1 sentence 1 number 5 or, if they are exempt from the marketing authorisation or if they do not require a prolongation, two years or, if they are registered medicinal products pursuant to Section 38 or medicinal products exempted from registration pursuant to Section 38 or Section 39 sub-section 3, five years following the publication pursuant to Section 11 sub-section 1b regarding the standard text pursuant to Section 11 sub-section 1 sentence 1 number 5. Up until the dates specified in each case pursuant to sentence 1, medicinal products may be placed on the market by the pharmaceutical entrepreneur; after these dates they may continue to be placed on the market by wholesalers and retailers accompanied by a package leaflet that corresponds to the regulations in force until 26 October 2012.
(2a) Any person who manufactures medicinal products pursuant to Section 13 sub-section 2a sentence 2 number 1 or 3 on 26 October 2012 shall notify the competent authority pursuant to Section 13 sub-section 2a sentence 3 thereof by 26 February 2013.
(3) In respect of the incorporation of the standard text pursuant to Section 11a sub-section 1 sentence 3, in the case of finished medicinal products that are on the market on 26 October 2012, the pharmaceutical entrepreneur shall submit to the competent higher federal authority the wording of the summary of expert information that corresponds to Section 11a together with the first application for prolongation of the authorisation after the publication pursuant to Section 11a sub-section 1 sentence 9 regarding the standard text pursuant to Section 11a sub-section 1 sentence 3; if such medicinal products do not require a prolongation, the obligation shall be valid for two years following the publication.
(4) In the case of marketing authorisations or registrations, the five-year validity period of which ends by 26 October 2013, the deadline contained in Section 31 sub-section 1 sentence 1 number 3, Section 39 sub-section 2c and Section 39c sub-section 3 sentence 1 shall continue to apply in the version in force up to 26 October 2012.
(5) The obligation pursuant to Section 22 sub-section 2 sentence 1 number 5a shall not apply to medicinal products that were authorised for placing on the market prior to 26 October 2012 or for which a proper application for authorisation was already submitted before 26 October 2012.
(6) Any person who is authorised to pursue the activity of a wholesaler up until 26 October 2012 and applied for a permit to operate a wholesale business in medicinal products by 26 February 2013 may, by way of derogation from Section 52a sub-section 1, pursue the medicinal product wholesale business until a decision is taken on the application submitted; Section 52a sub-section 3 sentences 2 to 3 shall not apply.
(7) The obligation pursuant to Section 63b sub-section 2 number 3 shall apply from 21 July 2015 to medicinal products authorised for marketing before 26 October 2012 or from the date on which the marketing authorisation is prolonged, should this be earlier. The obligation pursuant to Section 63b sub-section 2 number 3 shall apply from 21 July 2015 for medicinal products for which a proper application for marketing authorisation was submitted before 26 October 2012.
(8) Sections 63f and 63g shall apply to studies commenced after 26 October 2012.
(9) Any person who, on 2 January 2013 lawfully engages in the activity of a medicinal product broker and informs the competent authority of his/her activity by 2 May 2013 may continue to pursue this activity until such time as a decision is taken on the registration pursuant to Section 52c.
(10) Enterprises and establishments that otherwise trade in active substances must notify the competent authority of their activity by 26 April 2013.
(11) Any person who for retail trade purposes offers medicinal products for human use for sale at a distance on the internet must notify the competent authority of his/her activity, providing the particulars specified under Section 67 sub-section 8 by 24 March 2017.
(12) The requirements specified in Section 94 sub-section 1 sentence 3 number 1 shall apply to re-insurance contracts from 1 January.
Nineteenth sub-chapter
Transitional provision
Section 147
Transitional provisions arising out of the Third Act amending the regulations pertaining to medicinal products and other regulations
Section 63f sub-section 4 and Section 67 sub-section 6 shall apply until 31 December 2013 in the version in force until 12 August 2013 to non-interventional post-authorisation safety studies pursuant to Section 63f and tests pursuant to Section 67 sub-section 6, commenced prior to 13 August 2013.
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