Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER FIVE
Registration of medicinal products
Section 38
Registration of homeopathic medicinal products
(1) Finished medicinal products that are medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1 may only be placed on the market as homeopathic medicinal products within the purview of this Act, if they have been entered into the Register for Homeopathic Medicinal Products kept by the competent higher federal authority (registration). A marketing authorisation shall not be necessary; Section 21 sub-section 1 sentence 2 and sub-section 3 shall apply accordingly. A registration is not required for medicinal products that are placed on the market by a pharmaceutical entrepreneur in amounts of up to 1,000 packages per year, unless these are medicinal products:
1. that contain preparations made from substances pursuant to Section 3 number 3 or 4,
2. that contain more than the one-hundredth part of the smallest dose used in non-homeopathic medicinal products which are subject to prescription pursuant to Section 48 or,
3. in which the conditions contained in Section 39 sub-section 2 numbers 3, 4, 5, 6, 7 or 9 are present.
(2) The information, documents and expert opinions specified in Sections 22 to 24 shall be enclosed with the application for registration. This shall not apply to the information regarding the effects and therapeutic indications, the documents and expert opinions on the clinical trials, nor to information pursuant to Section 22 sub-section 2 numbers 5 and 5a and sub-section 7 sentence 2. The documents on the pharmaceutical-toxicological test are to be submitted if the safety of the product, especially as results from an adequately high degree of dilution, is not otherwise evident. Section 22 sub-section 1a shall apply mutatis mutandis.
Section 39
Decision on the registration of homeopathic medicinal products, procedural provisions
(1) The competent higher federal authority shall register the homeopathic medicinal product and assign the applicant the registration number in writing. Section 25 sub-sections 4 and 5 sentence 5 shall apply mutatis mutandis. The registration shall only be valid for the homeopathic medicinal product and its degrees of dilution as specified in the notice of registration. The competent higher federal authority can make the registration notification subject to conditions. Conditions may also be imposed subsequently. Section 28 sub-sections 2 and 4 shall apply.
(2) The competent higher federal authority shall refuse registration if:
1. the documents submitted are incomplete,
2. the medicinal product has not been sufficiently tested analytically in compliance with the prevailing standard of scientific knowledge,
3. the medicinal product does not possess the appropriate quality according to recognised pharmaceutical rules,
4. there is sufficient reason to suspect that, if used in keeping with its designated purpose, the medicinal product has harmful effects which exceed the bounds considered justifiable in the light of the knowledge available to medical science,
4a. the medicinal product is intended for administration to food-producing animals and contains a pharmacologically active constituent not listed in the Annex to Regulation (EU) No. 37/2010, as a substance for which the stipulation of maximum levels is not necessary,
5. the withdrawal period given is insufficient,
5a. the medicinal product, in so far as it is intended for administration to human beings, is intended neither for oral administration nor for external use,
5b. the medicinal product contains more than one part per 10,000 of the stock, or in the case of medicinal products intended for use in human beings, more than 1/100th part of the smallest dose used in allopathic medicinal products that are subject to prescription pursuant to Section 48,
6. the medicinal product is subject to a prescription, unless it exclusively contains substances listed in the Annex to Regulation (EU) No. 37/2010, as substances for which the stipulation of maximum levels is not necessary,
7. the medicinal product is not manufactured according to a procedure described in the homeopathic section of the Pharmacopoeia,
7a. the use of the individual active substances as homeopathic or anthroposophic medicinal products is not generally known,
8. a marketing authorisation has been granted for the medicinal product,
9. the placing on the market of a medicinal product or its use in animals would be in breach of legal provisions.
(2a) If the medicinal product has already been registered in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area, the registration is to be carried out on the basis of this decision unless a reason to refuse pursuant to sub-section 2 is present. For recognition of the registration by another Member State, Chapter 4 of Directive 2001/83/EC and, for medicinal products intended for use in animals, Chapter 4 of Directive 2001/82/EC shall apply mutatis mutandis; Article 29 paragraphs 4, 5 and 6, Articles 30 to 34 of Directive 2001/83/EC, Article 33 paragraphs 4, 5 and 6 and Articles 34 to 38 of Directive 2001/82/EC shall not apply.
(2b) The applicant shall notify the competent higher federal authority forthwith, enclosing the corresponding documents, in the event of any changes in the information and documents referred to in Section 38 sub-section 2 sentence 1. Section 29 sub-sections 1a, 1e, 1f and 2 to 2b shall apply mutatis mutandis. The obligation pursuant to sentence 1 shall be fulfilled by the registration holder after the registration has been granted. In the following cases, an application for a new registration shall be required:
1. in the case of a change in the composition of the active substances either in type or quantity, including a change in the potency level,
2. in the case of a change in the pharmaceutical form, in so far as a change pursuant to Section 29 sub-section 2a sentence 1 number 3 is not concerned,
3. (repealed)
(2c) The registration shall terminate after a period of five years has elapsed unless an application for prolongation is submitted not less than nine months before expiry of the term. For the expiry and prolongation of the registration, Section 31 shall apply mutatis mutandis provided that the grounds for refusal pursuant to sub-section 2 numbers 3 to 9 apply.
(2d) With respect to the withdrawal, revocation and suspension of the registration, Section 30 sub-section 1 sentence 1, sub-sections 2, 2a, 3 and 4 shall apply mutatis mutandis, under the proviso that the grounds for refusal pursuant to sub-section 2 numbers 2 to 9 apply.
(2e) Section 34 sub-section 1 sentence 1 numbers 1 to 7, sub-section 1a sentence 1 numbers 1, 4 and 5, sub-section 1a sentence 4, sub-sections 1b and 1d shall apply mutatis mutandis.
(3) For homeopathic medicinal products, the Federal Ministry is hereby empowered to issue, in compliance with the provisions on marketing authorisation by ordinance, not subject to the approval of the Bundesrat, provisions governing fees and expenses and the exemption from registration. The ordinance shall be issued in agreement with the Federal Ministry of Food and Agriculture in so far as medicinal products intended for administration to animals are concerned. Section 36 sub-section 4 shall apply mutatis mutandis to the amendment of an ordinance on the exemption from registration.
Section 39a
Registration of traditional herbal medicinal products
Finished medicinal products which are herbal medicinal products and medicinal products within the meaning of Section 2 sub-section 1, may be placed on the market as traditional herbal medicinal products only if they are registered by the competent higher federal authority. This shall also apply to herbal medicinal products containing vitamins or minerals provided that the action of the vitamins or minerals is ancillary to that of the traditional herbal medicinal product regarding the therapeutic indication or indications.
Section 39b
Registration documents for traditional herbal medicinal products
(1) The applicant must enclose the following information and documents with the registration application:
1. the information and documents referred to in Section 22 sub-sections 1, 3c, 4, 5 and 7 and Section 24 sub-section 1 number 1,
2. the results of analytical tests referred to in Section 22 sub-section 2 sentence 1 number 1,
3. the summary of the product characteristics of the medicinal product with the information referred to in Section 11a sub-section 1, taking into consideration the fact that it is a traditional herbal medicinal product,
4. bibliographic evidence of the traditional use or expert reports showing that the medicinal product in question, or a corresponding product has been in medicinal use by human beings or in animals for at least 30 years preceding the date of the application, including at least 15 years within the European Union and that under the stated conditions of use, the medicinal product is safe and the pharmacological effects or efficacy of the medicinal product are plausible based on use and experience over many years,
5. a bibliographic review of safety data together with an expert report pursuant to Section 24 and, where required, additional information and documents necessary for assessing the safety of the medicinal product,
6. any registrations or marketing authorisations obtained by the applicant in another Member State, or in a third country, to place the medicinal product on the market, and details of any decision to refuse to grant a registration or marketing authorisation and the reasons for any such decision.
Evidence of use over a period of 30 years pursuant to sentence 1 number 4 can also be provided if no special authorisation has been granted for placing a medicinal product on the market. It can also be provided if the number or quantity of active substances of the medicinal product has been reduced over this period. A corresponding medicinal product as referred to in sentence 1 number 4, is characterised by having the same or comparable active substances, irrespective of the excipients used, the same or similar intended use, equivalent strength and dosage and the same or similar route of administration as the medicinal product for which registration is applied.
(1a) The information pursuant to Section 22 sub-section 1 sentence 1 numbers 1 to 10 must be provided in German, the other information in the German or English language; other information or documents may also be submitted in the registration procedure in English instead of in German, in so far as information which is used for the labelling, the packaging leaflet or the expert information is not concerned.
(2) Instead of submitting the information and documents referred to in sub-section 1 sentence 1 numbers 4 and 5, in the case of medicinal products for use in human beings, reference can also be made to a Community or European Union herbal monograph pursuant to Article 16h paragraph 3 of Directive 2001/83/EC or its presence on the list pursuant to Article 16f of Directive 2001/83/EC.
(3) If the medicinal product contains more than one herbal active substance or substance pursuant to Section 39a sentence 2, the information referred to in sub-section 1 sentence 1 number 4 shall be submitted for the combination. If the individual active substances are not sufficiently well known, information shall be provided about the individual active substances.
Section 39c
Decision on the registration of traditional herbal medicinal products
(1) The competent higher federal authority shall register traditional herbal medicinal products and notify the applicant of the registration number in writing. Section 25 sub-sections 4 and 5 sentence 5 shall apply mutatis mutandis. The registration shall apply only for the herbal medicinal product listed in the notification. The competent higher federal authority can make the registration notification subject to conditions. Conditions may also be imposed subsequently. Section 28 sub-sections 2 and 4 shall apply mutatis mutandis.
(2) The registration shall be refused by the competent higher federal authority if the application does not contain the information and documents stipulated in Section 39b, if:
1. the qualitative or quantitative composition does not correspond to the information referred to in Section 39b sub-section 1 or the pharmaceutical quality is otherwise inadequate,
2. the therapeutic indications do not comply exclusively with those of traditional herbal medicinal products which, according to their composition and intended use, are intended for use in human beings without the need for medical supervision with respect to making a diagnosis, prescription or supervising the treatment,
3. the medicinal product can be harmful under normal conditions of use,
4. the safety of vitamins or minerals contained in the medicinal product has not been proved,
5. the information on traditional use is insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience,
6. the medicinal product is not exclusively intended for administration in a specific strength or dosage,
7. the medicinal product is not exclusively intended for oral or external use or for inhalation,
8. the time requirement stipulated in Section 39b sub-section 1 sentence 1 number 4 has not been fulfilled, or
9. a marketing authorisation pursuant to Section 25 or a registration pursuant to Section 39 has been granted for the traditional herbal medicinal product or a corresponding medicinal product,
10. the placing on the market of a medicinal product or its use in animals would be in breach of legal provisions.
For medicinal products intended for use in animals, the first sentence shall apply accordingly.
(3) The registration shall terminate after a period of five years has elapsed unless an application for prolongation is submitted not less than nine months before expiry of the term. For the expiry and prolongation of the registration, Section 31 shall apply accordingly provided that the reasons for rejection referred to in sub-section 2 apply.
Section 39d
Other procedural provisions for traditional herbal medicinal products
(1) On request, the competent higher federal authority shall notify the applicant and in the case of medicinal products intended for use in human beings, the European Commission and the competent authority of an EU Member State, of any decision it takes to refuse traditional-use registration and the reasons for the refusal.
(2) For medicinal products corresponding to Article 16d paragraph 1 of Directive 2001/83/EC, Section 25b shall apply mutatis mutandis. For medicinal products referred to in Article 16d paragraph 2 of Directive 2001/83/EC, a registration by another Member State shall be duly considered.
(3) On application, the competent higher federal authority can request the Committee on Herbal Medicinal Products, set up pursuant to Article 16h of Directive 2001/83/EC, for an opinion on the evidence of traditional use if there are doubts as to the fulfilment of the conditions referred to in Section 39b sub-section 1 sentence 1 number 4.
(4) Where a medicinal product has been used in the European Union, in human beings, for less than 15 years, but is otherwise eligible for registration pursuant to Sections 39a to 39c, the competent higher federal authority shall initiate the procedure envisaged under Article 16c paragraph 4 of Directive 2001/83/EC with the participation of the Committee for Herbal Medicinal Products.
(5) If a herbal substance, a herbal preparation or a combination thereof is removed from the list referred to in Article 16f of Directive 2001/83/EC, registrations pursuant to Section 39b sub-section 2 granted for traditional herbal medicinal products containing this substance intended for use in human beings shall be revoked unless the information and documents referred to in Section 39b sub-section 1 are submitted within three months.
(6) Section 34 sub-section 1 sentence 1 numbers 1 to 7, sub-section 1a sentence 1 numbers 1, 4 and 5, sub-section 1a sentence 4, sub-sections 1b and 1d shall apply mutatis mutandis.
(7) The applicant shall notify the competent higher federal authority forthwith, enclosing the corresponding documents, in the event of any changes in the information and documents pursuant to Section 39b sub-section 1 sentence 1, in conjunction with sub-section 2. Section 29 sub-sections 1a, 1e, 1f and 2 to 2b shall apply mutatis mutandis. The obligation pursuant to sentence 1 shall be fulfilled by the registration holder after the registration has been granted. In the following cases, an application for a new registration shall be required:
1. in the case of a change in the therapeutic indications, in so far as a change pursuant to Section 29 sub-section 2a sentence 1 number 1 is not concerned,
2. in the case of a change in the composition of the active substances either in type or quantity,
3. in the case of a change in the pharmaceutical form, in so far as a change pursuant to Section 29 sub-section 2a sentence 1 number 3 is not concerned,
(8) With respect to the withdrawal, revocation and suspension of the registration, Section 30 sub-section 1 sentence 1, sub-sections 2, 2a, 3 and 4 shall apply mutatis mutandis with the proviso that the grounds for refusal pursuant to Section 39c sub-section 2 apply.
(9) The Federal Ministry shall be authorised, in the case of traditional herbal medicinal products in accordance with provisions of the marketing authorisation, to enact provisions governing the fees and expenses of registrations by ordinance without the agreement of the Bundesrat. The ordinance shall be issued in agreement with the Federal Ministry of Food and Agriculture in so far as medicinal products intended for administration to animals are concerned.
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