Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER ELEVEN
Surveillance
Section 64
Conducting supervision
(1) Enterprises and establishments in which medicinal products are manufactured, tested, stored, packaged or placed on the market, in which they are otherwise traded, or that import medicinal products, or in which the records associated with the above-mentioned activities are kept, shall be subject in this regard to supervision by the competent authority; the same shall apply to enterprises and establishments that develop medicinal products, subject them to clinical trials, residue tests or acquire or administer specific medicinal products pursuant to Section 47a sub-section 1 sentence 1 or medicinal products intended for administration to animals, or in which the records associated with the above-mentioned activities are kept. The development, manufacture, testing, storage, packaging, import and placing on the market of active substances and other substances and tissues intended for the manufacture of medicinal products, any other form of trade in such active substances and substances, as well as the keeping of records connected to the stated activities, shall be subject to supervision in so far as they are regulated by an ordinance pursuant to Section 54, pursuant to Section 12 of the Transfusion Act or pursuant to Section 16a of the Transplantation Act. In the case of Section 14 sub-section 4 number 4 and Section 20b sub-section 2, the removal facilities and the laboratories shall be subject to supervision by the competent authority responsible for them locally; in the case of Section 20c sub-section 2 sentence 2, the commissioned enterprises shall be subject to supervision by the competent authority responsible for them locally. Sentence 1 shall also apply to persons carrying out these activities professionally, to persons carrying with them medicinal products not exclusively intended for personal use, to the sponsor of a clinical trial or his/her representative pursuant to Section 40 sub-section 1 sentence 3 number 1, as well as to persons or associations collecting medicinal products for others. Sentence 1 shall not apply to reconstitution in so far as medicinal products which are intended for use in clinical trials are not concerned.
(2) Persons in charge of supervision shall carry out this activity as their main profession. The competent authority may call in experts. In so far as blood preparations, tissues and tissue preparations, radiopharmaceuticals, medicinal products produced using genetic engineering, sera, vaccines, allergens, advanced therapy medicinal products, xenogeneic medicinal products or active substances or other substances of human, animal or microbial origin or which have been manufactured using genetic engineering are concerned, the competent authority shall summon members of the competent higher federal authority to participate as experts. With regard to pharmacies that are not hospital pharmacies or that do not require an authorisation in compliance with Section 13, the competent authority may commission experts to carry out the supervision.
(3) The competent authority shall satisfy itself that the provisions on medicinal products, on active substances and other substances intended for use in the manufacture of medicinal products, as well as on tissues, on advertising in the field of medicine, of Chapter Two of the Transfusion Act, of Chapters 2, 3 and 3a of the Transplantation Act, and those on pharmacies, are observed. To this end, the competent authority shall, based on a surveillance system, paying special attention to possible risks, with appropriate frequency and to an appropriate extent, also conduct unannounced inspections where necessary and stipulate effective follow-up measures. It shall also commission the official testing of medicinal product samples.
(3a) Enterprises and establishments requiring an authorisation pursuant to Sections 13, 20c, 72, 72b sub-section 1 or Section 72c, as well as veterinary house dispensaries, are to be inspected every two years, as a rule, pursuant to sub-section 3. The competent authority shall grant an authorisation pursuant to Sections 13, 20c, 52a, 72, 72b sub-section 1 or Section 72c only after having satisfied itself, by means of an inspection, that the requirements for granting an authorisation are fulfilled.
(3b) The competent authority shall conduct the inspections to monitor compliance with the provisions governing the trade in medicinal products for human use in accordance with the guidelines of the European Commission pursuant to Article 111a of Directive 2001/83/EC, in so far as the supervision of the conduct of clinical trials is not concerned. It shall co-operate with the European Medicines Agency by exchanging information on planned and conducted inspections as well as in the co-ordination of inspections of enterprises and facilities in countries that are not Member States of the European Union or other States Parties to the Agreement on the European Economic Area.
(3c) The inspections can also be carried out at the request of another Member State, the European Commission or the European Medicines Agency. Without prejudice to any other agreements between the European Union and countries that are not members of the European Union or other States Parties to the Agreement on the European Economic Area, the competent authority can require a manufacturer in the country that is not a member of the Union or a State Party to the Agreement on the European Economic Area to submit him/herself to an inspection in accordance with the requirements of the European Union.
(3d) A report shall be drawn up on the inspection. The competent authority that conducted the inspection shall notify the inspected enterprises, facilities or persons of the content of the draft report and give them opportunity for comment before it is completed.
(3e) If, after evaluation of the comments pursuant to sub-section 3d sentence 2, the inspection leads to the conclusion that the enterprises, facilities or persons do not comply with the statutory provisions, this information shall be entered into the database referred to in Section 67a, in so far as the principles and guidelines of good manufacturing practice or good distribution practice as provided for by Community legislation on medicinal products for human use or the principles and guidelines of good manufacturing practice as provided for by Community legislation on medicinal products for animal use are affected.
(3f) Within a period of 90 days following an inspection to determine compliance with good manufacturing practice or good distribution practice, the inspected enterprises, facilities or persons shall be issued with a certificate if the inspection has resulted in the conclusion that the corresponding principles and guidelines are being complied with. The certificate on compliance with the principles and guidelines of good manufacturing practice shall be valid for not more than three years, the certificate on compliance with the principles and guidelines of good distribution practice no more than five years. The certificate shall be withdrawn if it subsequently becomes known that the conditions were not fulfilled; it shall be revoked if the conditions no longer apply.
(3g) The information regarding the issue, refusal, withdrawal or revocation of a certificate on compliance with the principles and guidelines of good manufacturing practice is to be entered into a database pursuant to Section 67a. This shall also apply to the issuing, withdrawal, revocation or suspension of an authorisation pursuant to Section 13, or Section 72 sub-sections 1 and 2, as well as to the registration and deletion of medicinal product brokers or of enterprises and facilities that manufacture, import or otherwise trade in active substances without requiring an authorisation. The information regarding the issue, refusal, withdrawal or revocation of an authorisation pursuant to Section 52a, as well as a certificate of compliance with the principles and guidelines of good distribution practice, is to be entered into a database of the European Medicines Agency pursuant to Article 111 (6) of Directive 2001/83/EC.
(3h) Sub-sections 3b, 3c and 3e to 3g shall apply neither to veterinary in-house dispensaries nor to enterprises and establishments that exclusively manufacture medicated feeding stuffs. Furthermore, sub-section 3d sentence 2 shall not apply to veterinary in-house dispensaries.
(3i) By way of derogation from sub-section 3c, the competent authority shall decide, on a duly justified request by another Member State of the European Union into which tissues or tissue preparations that were previously imported into the territory governed by this Act are to be imported, to inspect an importing tissue establishment that is subject to the obligation to obtain an authorisation pursuant to Section 72b sub-section 1 or Section 72c sub-section 1, or take other supervisory measures. The other Member State shall first be given an opportunity to comment. Sentences 1 and 2 shall apply mutatis mutandis to a duly justified request by another Member State of the European Union, into which haematopoietic stem cells and stem cell preparations derived from peripheral blood or umbilical cord blood that were previously imported into the territory governed by this Act are to be imported, to inspect an importing establishment that is subject to the obligation to obtain an authorisation pursuant to Section 72b sub-section 4 or Section 72c sub-section 4 sentence one in conjunction with sub-section 1, or take other supervisory measures.
(3j) In the event of an inspection pursuant to sub-section 3i, the competent authority can, based on the request by the competent authority of the other Member State, permit persons designated by said Member State to attend the inspection. The competent authority must justify its rejection of the request to the competent authority of the other Member State. The accompanying persons shall be authorised, together with the persons in charge of supervision, to enter and inspect properties, office premises and means of transport during normal business hours.
(4) The persons charged with monitoring shall be authorised
1. to enter and inspect during normal business hours properties, office premises, operating rooms, transport facilities and also, for the prevention of imminent danger to public order and security, residential housing and to take pictures for documentation purposes in office premises, operating rooms and means of transport in which the activities referred to in sub-section 1 are carried out; the fundamental right to the inviolability of the home (Article 13 of the Basic Law) shall be limited in this regard,
2. to review documentation on the development, manufacture, testing, clinical trial or residue testing, acquisition, import, storing, packaging, marketing and other whereabouts of the medicinal products as well as on the advertising material currently in circulation and on the liability coverage required pursuant to Section 94,
2a. to prepare or request transcripts or photocopies of documents pursuant to number 2 or printouts or copies of data storage media on which documents pursuant to number 2 are stored in so far as personal data from patients are not concerned,
3. to demand from natural and legal persons and associations without legal capacity all the necessary information, in particular on the company operations specified in number 2,
4. to issue provisional orders also on the closing of the company or facility, in so far as this is deemed necessary for the prevention of imminent danger to public order and safety.
(4a) If it is required for the implementation of this Act or of ordinances issued on the basis of this Act or Regulation (EC) No. 726/2004, experts from the Member States of the European Union may exercise the powers contained in sub-section 4 number 1, if they are in the company of the persons responsible for the supervision.
(5) The person under obligation to give information may refuse to answer certain questions if he/she has reason to fear that answering them could expose him/her or one of the relatives specified in Section 383 sub-section 1 numbers 1 to 3 of the German Code of Civil Procedure (Zivilprozeßordnung) to the danger of prosecution under criminal law or to a lawsuit under the Act on Administrative Offences (Gesetz über Ordnungswidrigkeiten).
(6) The Federal Ministry is hereby empowered, to issue, by ordinance subject to the approval of the Bundesrat, regulations governing the fulfilment of supervisory tasks in cases where medicinal products are imported into the territory governed by this Act, by a pharmaceutical entrepreneur who has no registered place of business in the territory governed by this Act, in so far as necessary for the implementation of the provisions governing the trade in medicinal products as well as advertising in the field of medicine. In the process, the main responsibility for supervisory tasks, which arise out of the import of a medicinal product from a specific Member State of the European Union, can be assigned in each case to a specific Land or to a facility supported by one of the Laender. The ordinance shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry, in so far as medicinal products intended for administration to animals are concerned.
Section 65
Sampling
(1) To the extent necessary for the implementation of the provisions on the trade in medicinal products, on advertising in the field of medicine of Chapter Two of the Transfusion Act, of Chapters 2, 3 and 3a of the Transplantation Act and on pharmacies, those persons in charge of supervision shall be authorised to demand or to take samples of their own selection, against receipt, for the purposes of testing them. This authorisation shall extend to the taking of samples of feedingstuffs, trough water and from living animals, including the necessary interventions on these animals for this purpose. In so far as the pharmaceutical entrepreneur does not explicitly waive his/her right thereto, a part of the sample or, if the sample is not divisible in parts of equal quality without endangering the purpose of the test, a second sample of the same type as the sample taken, shall be left behind.
(2) The samples left behind shall be officially closed or sealed. They shall be marked with the date on which the sample was taken and the date after which the closing or sealing of the sample is deemed to have been removed.
(3) For samples that are not drawn from the pharmaceutical enterprise, an appropriate compensation shall be paid by the pharmaceutical entrepreneur if this right is not explicitly waived.
(4) Eligible for appointment as a private expert for the testing of samples left behind pursuant to sub-section 1 sentence 2 shall only be a person who:
1. has the expert knowledge pursuant to Section 15. The practical experience pursuant to Section 15 sub-sections 1 and 4 can be replaced by practical experience in the control and assessment of medicinal products in medicinal product control laboratories or in other similar medicinal product institutes,
2. is reliable enough to perform his/her duties as an expert for the testing of official samples and
3. has adequate premises and facilities at his/her disposal for the intended testing and assessment of medicinal products.
Section 66
Obligation to tolerate and collaborate
(1) The party subject to supervision in compliance with Section 64 sub-section 1 shall be obliged to tolerate the measures defined in Sections 64 and 65 and to give full support to the persons in charge of supervision in the fulfilment of their duties, in particular, indicating to them, upon request, the premises and transport facilities, opening rooms, containers and receptacles, giving information and enabling the taking of samples. The same requirement shall apply to the qualified person referred to in Section 14, the responsible person pursuant to Section 20c, the graduated plan officer, information officer, the responsible person pursuant to Section 52a and the chief investigator, and their representatives, also with regard to queries by the competent higher federal authority.
(2) The obligation to tolerate and collaborate pursuant to sub-section 1 shall apply mutatis mutandis to measures by the higher federal authorities pursuant to Section 25 sub-section 5 sentence 4 or sub-section 8 sentences 2 and 3 or pursuant to Section 62 sub-section 6.
Section 67
General notification requirement
(1) Enterprises and establishments that develop or manufacture medicinal products, subject medicinal products to clinical trials or to residue tests, test, store, package, import and place them on the market, or are otherwise engaged in the trade in medicinal products shall accordingly notify the competent authorities and, in the case of a clinical trial on human beings the competent higher federal authority as well, before taking up these activities. Sentence 1 shall apply mutatis mutandis to facilities that procure tissues, conduct the laboratory test necessary for the procurement, process, preserve, test, store, import or place them on the market. Notification shall be given of the development of medicinal products in so far as it is governed by an ordinance pursuant to Section 54. The same shall apply to persons practising these activities on a self-employed and professional basis as well as to persons or associations who collect medicinal products for others. The notification shall state the type of activity and the factory site; if medicinal products are collected, details shall be given regarding the type of collection made and the place of storage. If, according to sentence 1, notification is to be given of a clinical trial on human beings, the sponsor of the clinical trial, his/her representative pursuant to Section 40 sub-section 1 sentence 3 number 1 if any, as well as the investigator and his/her deputy, where necessary also indicating his/her status as chief investigator (Leiter der klinischen Prüfung), shall also be designated by name to the competent authority. Sentences 1 to 5 shall apply mutatis mutandis to enterprises and establishments that manufacture, test, store, package, import, market or otherwise trade in active substances or other substances intended for use in the manufacture of medicinal products, in so far as these activities are regulated by an ordinance pursuant to Section 54. Sentence 1 shall not apply to reconstitution in so far as medicinal products which are intended for use in clinical trials are not concerned. Sentences 1 to 5 and 7 shall also apply to enterprises and establishments that keep records associated with the above-mentioned activities.
(2) If medicinal product manufacture is envisaged, for which an authorisation as defined in Section 13 is not necessary, notification shall be made of the medicinal products indicating their name and composition.
(3) Notification shall likewise be made of subsequent changes. In the case of enterprises and facilities that manufacture, import or otherwise trade in active substances, a yearly notification shall be sufficient if the changes will not have an effect on the quality or safety of the active substances.
(3a) If notification is to be made at the start of a clinical trial on human beings pursuant to sub-section 1, the competent higher federal authority shall also be notified of the progression, termination and results of the clinical trial; further details shall be specified in the ordinance pursuant to Section 42.
(3b) Enterprises and establishments that keep records associated with the activities specified in sub-section 1 sentences 1 to 4 and 7, outside of the premises listed in the authorisation pursuant to Sections 13, 20b, 20c, 52a, 72b or 72c, shall notify the competent authorities accordingly prior to commencing activities; this shall also apply to subsequent modifications.
(4) Sub-sections 1 to 3 shall not apply to those persons holding an authorisation under Section 13, Section 20b, Section 20c, Section 52a, Section 72, Section 72b or 72c, or to pharmacies pursuant to the Pharmacies Act. Sub-section 2 shall not apply to veterinary in-house dispensaries.
(5) A person who, in his/her capacity as a pharmaceutical entrepreneur, places on the market a medicinal product which, pursuant to Section 36 sub-section 5, is exempted from the obligation to obtain a marketing authorisation shall notify the competent higher federal authority and the competent authority of this beforehand. The notification shall include the name used for the medicinal product and the non-active substances used, in so far as they are not specified in the ordinance pursuant to Section 36 sub-section 1, as well as the actual composition of the medicinal product in so far as the ordinance pursuant to Section 36 sub-section 1 allows for differences in this respect. Also to be notified are any changes in the information and the termination of the placing on the market.
(6) Any person who conducts tests which serve the purpose of gathering knowledge resulting from the use of authorised or registered medicinal products shall immediately notify the competent higher federal authority, the Federal Association of Panel physicians, the Central Federal Association of the health insurance funds, as well as the Association of Private Health Insurance Funds. In this regard, the location, time, purpose and observation plan of the non-interventional study shall be stated and the names of the participating physicians revealed to the Federal Panel physicians’ Association and the Central Federal Association of the health insurance funds. Remuneration paid to physicians for their participation in tests pursuant to sentence 1 shall be calculated, as to type and amount, in such a way as to provide no incentive for the preferential prescription or recommendation of specific medicinal products. In so far as participating physicians provide benefits that are reimbursed by the statutory health insurance, the type and amount of the compensation actually paid to them in each case shall be communicated as well as a copy of each of the contracts signed with them and, in each case, a description of the costs incurred for the participating physicians and a justification for the appropriateness of the compensation shall be submitted in the case of notifications pursuant to sentence 1. In so far as modifications are made to the information specified in sentence 4, the information pursuant to sentence 4 shall be communicated in its entirety in the modified, updated form within four weeks following the end of each quarter; the compensation actually paid is to be communicated and assigned to the participating physicians giving the name and the lifelong physician identification number. Within one year following the completion of the data collection process, the number of patients participating in each case, and in total, as well as the type and amount of the compensation paid in each case and in total are to be communicated giving the total number of participating physicians. The information pursuant to this sub-section is to be transmitted electronically. In the case of tests using medicinal products intended for use in human beings, a final report shall be transmitted to the competent higher federal authority within one year following completion of the data collection process. Section 42b sub-section 3 sentences 1 and 4 shall apply mutatis mutandis. The information pursuant to this sub-section is to be transmitted electronically in the case of tests using medicinal products intended for use in human beings. For this purpose, the competent higher federal authorities are to publish electronic format specifications; the competent higher federal authority is to make the notifications received and the final reports available to the public through an internet portal. Section 42b sub-section 3 sentence 4 shall apply mutatis mutandis to the publication of the notifications. Sentences 4 to 6 shall not apply to notifications to the competent higher federal authority. The Federal Association of Panel physicians, the Central Federal Association of the Health Insurance Funds, as well as the Association of Private Health Insurance Funds shall, by mutual agreement, stipulate and publish formatting specifications for the electronic transmission of the information to be sent to them. In the case of medicinal products intended for use in animals, notifications pursuant to sentence 1 shall only be made to the competent higher federal authority. Sentences 1 to 12 and 14 shall not apply to post-authorisation safety studies pursuant to Section 63f.
(7) Any person who intends to introduce medicinal products that are authorised for placing on the market, by another pharmaceutical entrepreneur, in another Member State of the European Union into the territory governed by this Act on a commercial or professional basis, for the purpose of placing them on the market within the purview of this Act, shall notify the marketing authorisation holder of this intention before commencing activities. In the case of medicinal products that have been authorised for marketing pursuant to Regulation (EC) No. 726/2004, sentence 1 shall apply subject to the proviso that the notification must be transmitted to the marketing authorisation holder as well as the European Medicines Agency. A fee shall be paid to the Agency for monitoring compliance with the requirements laid down in the European Union legislation on medicinal products and in the marketing authorisations; the fee shall be determined based on European Union legislation.
(8) Any person who, for the purpose of retail trading, wishes to offer medicinal products for human use on the internet for sale at a distance, shall notify the competent authority before commencing activities and do so stating his/her name or company name and the address of the location from which the medicinal products are to be supplied and the address of every internet website including all of the necessary information for their identification. (2) Notification shall likewise be made of subsequent changes. The competent authority shall transmit this information to a database pursuant to Section 67a. The internet website pursuant to sentence 1 must carry the name and address of the competent authority and its other contact data, the common logo for sale at a distance pursuant to Article 85c of Regulation 2001/83/EC, as well as a hyperlink to the internet website of the German Institute for Medical Documentation and Information (DIMDI).
Section 67a
Database-supported information system
(1) The federal and Land authorities responsible for the implementation of this Act shall collaborate with the German Institute of Medical Documentation and Information (DIMDI) to set up a central information system for medicinal products and active substances as well as their manufacturer or importer, which can be used jointly. This information system shall collate all of the important data necessary for the fulfilment of the specific tasks affecting more than one authority. The German Institute for Medical Documentation and Information shall set up this information system on the basis of the data supplied to it by the competent authorities or higher federal authorities pursuant to the ordinance issued pursuant to sub-section 3 and shall be responsible for its operation. Data from the information system shall be transmitted to the competent authorities and higher federal authorities for fulfilment of their legally stipulated duties and to the European Medicines Agency. The competent authority and higher federal authorities shall have access, in addition, to current data from the information system for the fulfilment of their legally stipulated duties. Transmission to other agencies shall be permissible in so far as this is provided for in the ordinance issued pursuant to sub-section 3. The German Institute for Medical Documentation and Information shall be entitled to charge fees for its services. Such fees shall be listed in a catalogue of fees which is subject to the consent of the Federal Ministry.
(2) The German Institute for Medical Documentation and Information shall provide access to generally available databases which contain information on medicinal products through an internet portal. The internet portal will be connected with the European internet portal for medicinal products set up by the European Medicines Agency pursuant to Article 26 of Regulation (EC) No. 726/2004. Furthermore, the German Institute for Medical Documentation and Information shall provide information on the offering of medicinal products for human use for sale at a distance by means of a generally accessible internet portal. This internet portal will be connected with the website operated by the European Medicines Agency that contains information on sale at a distance and on the logo for sale at a distance. The German Institute for Medical Documentation and Information shall publish the addresses of the internet portals in the Federal Gazette.
(3) The Federal Ministry is hereby empowered to grant, in agreement with the Federal Ministry of the Interior and the Federal Ministry for Economic Affairs and Energy, by ordinance subject to the approval of the Bundesrat, the power to process and utilize data for the purposes defined in sub-sections 1 and 2 and to collect data for the purposes contained in sub-section 2, and to is-sue regulations governing the transmission of data by federal and Land authorities to the German Institute for Medical Documentation and Information, including personal and enterprise-related data, for the purposes regulated by this Act, as well as the type and scope of such data and the requirements to be placed thereon. The ordinance in question may also contain provisions stipulating that notifications may or must be made on electronic or optical storage media, in so far as required for the proper implementation of the regulations governing the trade in medicinal products. The ordinance shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry, the Federal Ministry of the Interior and the Federal Ministry for Economic Affairs and Energy, where medicinal products intended for administration to animals are concerned.
(3a) The Federal Ministry of Food and Agriculture is hereby empowered, in agreement with the Federal Ministry, the Federal Ministry of the Interior and the Federal Ministry for Economic Affairs and Energy, by ordinance subject to the approval of the Bundesrat to adopt regulations governing the transmission of data, including personal and enterprise-related data, through the German Institute for Medical Documentation and Information (DIMDI) to federal and Land authorities for the purpose of conducting repeated observations, tests and assessments to identify risks for human and animal health from specific medicinal products that are intended for use in animals (pharmacovigilance of veterinary medicinal products), as well as governing the type and amount of data and the requirements placed on the data. Sub-section 3 sentence 2 shall apply mutatis mutandis.
(4) The ordinance referred to in sub-sections 3 and 3a shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety in the case of radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used.
(5) The German Institute for Medical Documentation and Information shall take the necessary measures to ensure that the data are transmitted only to authorised persons and that only such persons receive access to them.
Section 67b
EU Compendium of Tissue Establishments, EU Compendium of Tissue and Cell Products, obligations to inform
(1) The competent authorities of the Laender shall enter the information contained in Annex VIII of Directive 2006/86/EC in the latest applicable version into the EU Compendium of Tissue Establishments. They shall ensure that every establishment is unmistakably issued an EU tissue establishment number.
(2) In the case of necessary modifications, the competent authorities shall update the EU Compendium of Tissue Establishments without delay, at the latest within ten working days. The following shall be considered to be changes pursuant to sentence 1, in particular:
1. the first granting of an authorisation to facilities that conduct activities that require an authorisation, involving tissues, tissue preparations, haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood,
2. modifications to the authorisation, including modifications regarding:
a) a new type of tissues, tissue preparations, haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood,
b) a new activity involving tissues, tissue preparations, haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood, or
c) new incidental provisions regarding the authorisation,
3. every withdrawal or revocation of the authorisation,
4. the voluntary, also partial, discontinuance of the activity by a facility,
5. modifications to the information on a facility, within the meaning of Annex VIII of Directive 2006/86/EC in the latest applicable version, as well as
6. modifications owing to incorrect data having been entered into the EU Compendium of Tissue Establishments.
(3) The competent authorities shall inform the competent authorities of another Member State of the European Union, if:
1. they become aware of incorrect information in the EU Compendium of Tissue Establishments, that concerns said Member State, or
2. they become aware of a serious breach of the provisions governing the Single European Code (SEC) in connection with said Member State.
(4) The competent authorities shall inform the European Commission and the competent authorities of the other Member States of the European Union if the EU Tissue and Cell Product Compendium needs to be updated.
Section 68
Obligations to notify and to inform
(1) The federal and Land authorities and agencies responsible for the implementation of this Act shall:
1. notify each other of the authorities, agencies and experts responsible for the enforcement of the Act and,
2. in instances of contravention and suspected contravention of the provisions contained in the medicinal product legislation, the legislation on health products advertising or on pharmacies, for their individual jurisdictions, inform each other immediately and support each other’s investigative activities.
(2) The authorities specified in sub-section 1:
1. shall furnish the competent authority of another Member State of the European Union with information, or, in the case of medicinal products for human use the European Medicines Agency, in response to a duly justified request, and shall transmit to it the necessary certificates and documents in so far as necessary to monitor compliance with the medicinal product-related regulations, the legislation on health products advertising and on pharmacies or for the prevention of medicinal product risks,
2. shall investigate all of the facts of which it is notified by the requesting authority of another Member State and shall notify said authority of the results of the investigation.
(3) The authorities specified in sub-section 1 shall provide the competent authorities of another Member State and the European Medicines Agency or the European Commission with all of the information which is necessary to monitor compliance with the medicinal product-related regulations, as well as the legislation on health products advertising and on pharmacies in force in that Member State or for the prevention of medicinal product risks. In cases of infringement or suspected infringement, the competent authorities of other Member States, the Federal Ministry, the Federal Ministry of Food and Agriculture, as well as the European Medicines Agency, in so far as medicinal products intended for administration to animals are concerned, and the European Commission may also be informed.
(4) The authorities specified in sub-section 1 may, if necessary for the implementation of requirements stipulated in medicinal product-related legislation, the legislation on health products advertising and on pharmacies, or for the prevention of medicinal product risks, also inform the competent authorities of other states and the competent offices at the Council of Europe. Sub-section 2 number 1 shall apply mutatis mutandis. States Parties to the Agreement on the European Economic Area that are not Member States of the European Union shall be informed through the European Commission.
(5) Communication with the competent authorities of other states, Council of Europe offices, the European Medicines Agency, and with the European Commission shall be the prerogative of the Federal Ministry. The Federal Ministry may transfer this power to the competent higher federal authority or, by means of an ordinance with the approval of the Bundesrat, to the competent higher authorities of the Laender. Furthermore, in individual cases, the Federal Ministry can transfer the above-mentioned power to the competent higher authority of the Land if the latter gives its consent. The higher authorities of the Laender are authorised to transfer the powers specified in sentences 2 and 3 to other authorities. In so far as medicinal products intended for administration to animals are concerned, the Federal Ministry of Food and Agriculture shall supersede the Federal Ministry. In such a case, the ordinance shall be issued pursuant to sentence 2 in agreement with the Federal Ministry.
(5a) Where the supervision of the advertising of medicinal products intended for use in human beings is concerned, the Federal Office of Consumer Protection and Food Safety shall be responsible for the correspondence with the competent authorities of other Member States of the European Union and the European Commission with respect to the implementation of Regulation (EC) No. 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (Regulation on consumer protection cooperation) (OJ L 364, p. 1) amended by Article 16 number 2 of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005, (OJ L 149, p. 22) as the central liaison office.
(6) In the cases provided for in sub-section 3 sentence 2 and sub-section 4, personal data shall not be transmitted if so doing will have an adverse effect on interests of the affected person which are worthy of protection especially if, on the side of the recipient, an adequate standard of data protection is not guaranteed. Personal data may be transmitted, even if the recipient cannot guarantee an adequate standard of data protection, if necessary for reasons of health protection.
Section 69
Measures by the competent authorities
(1) The competent authorities shall issue the necessary directives to rectify any offences which have been identified and to prevent offences in the future. They may, in particular, prohibit the marketing of medicinal products or active substances and order their recall from the market and seize them if:
1. the required marketing authorisation or registration of the medicinal product has not been submitted or if their suspension has been ordered,
2. the medicinal product or the active substance has not been manufactured according to the recognised pharmaceutical rules or does not possess the appropriate quality in keeping with recognised pharmaceutical rules,
2a. there is sufficient reason to suspect that the medicinal product or the active substance is counterfeit,
3. the medicinal product is lacking in therapeutic efficacy,
4. there is sufficient reason to suspect that the medicinal product has harmful effects which exceed the bounds considered justifiable according to the prevailing standard of scientific knowledge,
5. the prescribed quality controls have not been carried out, or
6. the authorisation required for the manufacture of the medicinal product or the active substances or the introduction into the purview of this Act has not been granted or a reason for the withdrawal or the revocation of the permit pursuant to Section 18 sub-section 1 exists.
7. the authorisation required to engage in wholesale trading under Section 52a has not been granted or a reason for the withdrawal or the revocation of the authorisation pursuant to Section 52a sub-section 5 exists.
In the case described in sentence 2 numbers 2 and 4, the competent higher federal authority may order a medicinal product to be recalled from the market if its actions are in connection with measures pursuant to Section 28, Section 30, Section 31 sub-section 4 sentence 2 or Section 32 sub-section 5 to prevent risks posed by medicinal products to human and animal health. The decision of the competent higher federal authority pursuant to sentence 3 is immediately enforceable. In so far as the medicinal products referred to in sentence 2 number 4 are medicinal products for animal use, it shall only apply to their use in keeping with the intended purpose.
(1a) In the case of medicinal products for which a marketing authorisation or an authorisation:
1. pursuant to Regulation (EC) No. 726/2004, or
2. within the framework of the recognition procedure pursuant to Chapter 4 of Directive 2001/83/EC or Chapter 4 of Directive 2001/82/EC, or
3. on the basis of an expert opinion of the Committee provided for in Article 4 of Directive 87/22/EEC of 22 December 1986 prior to 1 January 1995,
has been issued, the competent higher federal authority shall inform the Committee on Human Medicinal Products or the Committee on Veterinary Medicinal products about any observed violation of the medicinal product regulations, in accordance with the procedures envisaged by the above-mentioned legal acts, submitting at the same time detailed grounds and details of the proposed procedure. In the case of these medicinal products, the competent authorities may take the measures necessary to eliminate observed violations and to prevent future violations before informing the Committee, in so far as these are urgently needed to guarantee the protection of human or animal health or the protection of the environment. In the cases described in sentence 1 numbers 2 and 3, the competent authorities shall inform the European Commission and the other Member States, in the cases described in sentence 1 number 1, the Commission of the European Communities and the Medicines Agency, of the reasons for these measures by the following working day, at the latest, through the channel of the competent higher federal authority. In the case of sub-section 1 sentence 2 numbers 2a and 4, the competent higher federal authority can also order the suspension of the marketing authorisation or the recall of a medicinal product if such action is urgently needed to ensure the protection of the legal rights specified in sentence 2; in such a case sentence 3 shall apply mutatis mutandis.
(2) The competent authorities may prohibit the collection of medicinal products if suitable storage of the medicinal products is not guaranteed or if there is sufficient reason to suspect that the medicinal products collected will be used improperly. Collected medicinal products may be seized if, as a result of inappropriate storage or through their distribution, human and animal health will be endangered.
(2a) The competent authorities may furthermore seize medicinal products intended for administration to animals as well as substances and preparations from substances within the meaning of Section 59a if facts justify the assumption that provisions on the trade in medicinal products have not been observed.
(3) The competent authorities may seize advertising material which fails to comply with the regulations governing the trade in medicinal products and advertising in the field of health.
(4) In the case of sub-section 1 sentence 3, the competent higher federal authority may also issue a public warning.
(5) In the case of a medicinal product for human use, the dispensing of which was prohibited or that was removed from the market because:
1. the prerequisites for the placing on the market did not exist or no longer exist,
2. the medicinal product does not match the declared composition with regard to type and quantity, or
3. the testing of the medicinal product or of the ingredients and intermediate products was not conducted or another requirement or prerequisite for the granting of the manufacturing authorisation was not fulfilled,
the competent authority can, in consultation with the competent higher federal authority, in exceptional cases, allow its supply to patients who are already being treated with the product during a transition period if this is medically justifiable and indicated for the affected person.
Section 69a
The supervision of substances which can be used as medicinal products for animals
Sections 64 to 69 shall apply mutatis mutandis to the enterprises, facilities and persons specified in Section 59c as well as to the enterprises, facilities and persons who manufacture, store, import or place on the market substances listed in Table 2 of the Annex to Commission Regulation (EU) No. 37/2010 of 22 December 2009, on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15 of 20.1.2010, p. 1), in the latest applicable version.
Section 69b
Use of specific data
(1) The authorities responsible for the regulations governing food, feed, animal welfare and animal health and the collection of data for the notification and registration of animal-keeping enterprises shall transmit the data necessary for the fulfilment of its duties, upon request, to the competent authority responsible for the supervision pursuant to Section 64 sub-section 1 sentence 1 second half sentence.
(2) The data may be kept for three years. The three-year deadline shall begin at the end of the year in which the data is transmitted. When the deadline has expired, the data shall be erased unless they may be kept for a longer period on the basis of other provisions.
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