Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
Section 20b
Authorisation for the procurement of tissues and the pertinent laboratory testing
(1) Any establishment seeking to procure tissues intended for human applications within the meaning of Section 1a number 4 of the Transplantation Act (removal establishments) or seeking to conduct the laboratory testing necessary for such procurement, shall require an authorisation from the competent authority. Procurement within the meaning of sentence 1 is the direct or extracorporeal removal of tissues including all measures that are intended to maintain the tissues in a processable state, clearly identifiable and transportable. The authorisation may only be refused if:
1. an appropriately qualified person (the responsible person pursuant to Section 20b) with the necessary professional experience who, in the case of a removal establishment, can also be the medical person within the meaning of Section 8d, sub-section 1, sentence 1 of the Transplantation Act is not present,
2. additional participating personnel is insufficiently qualified,
3. appropriate rooms for the specific tissue procurement or for the laboratory testing are not available,
4. it is not guaranteed that the procurement of tissues or the laboratory testing are conducted according to the state of medical science and technology and according to the provisions contained in Chapters 2, 3 and 3a of the Transplantation Act, or
5. the responsible person pursuant to Section 20b or the applicant is not sufficiently reliable in the performance of his/her job.
The competent authority may dispense with an inspection within the meaning of Section 64 sub-section 3 sentence 2, prior to the granting of an authorisation pursuant to this provision. The authorisation is granted to the removal establishment by the competent authority for a specific facility and for a specific tissue and, to the laboratory, for a specific site and for specific activities and may provide for the possibility of tissue removal outside of the premises described in sentence 3 number 3, by personnel dispatched by the removal facility. In the process, the competent authority may involve the competent higher federal authority.
(1a) Section 20c sub-section 4 sentences 1 and 2 and sub-section 5 apply mutatis mutandis.
(2) An individual authorisation pursuant to sub-section 1 shall not be required by a person conducting such activities on a contractual basis for a manufacturer or a processor who is in possession of an authorisation pursuant to Section 13 or Section 20c for the processing of tissue or tissue preparations. In this case, the manufacturer or processor shall notify the local competent authority responsible for the removal establishment or the laboratory of the latter and shall include, with the notification, the information and documents pursuant to sub-section 1 sentence 3. One month subsequent to the notification pursuant to sentence 2, the manufacturer or processor shall notify the competent authority responsible for him/her of the removal establishment or the laboratory unless the competent authority responsible for the removal establishment or the laboratory has objected. In exceptional cases, the deadline pursuant to sentence 3 can be extended for an additional two months. The manufacturer or processor shall be informed thereof before expiry of the deadline and shall be notified of the grounds. If the competent authority has objected, the deadlines pursuant to sentences 3 and 4 shall be suspended until the grounds for the objection have been rectified. Sub-section 1 sentences 3 to 6 shall apply mutatis mutandis provided that the authorisation pursuant to sub-section 1 sentence 5 is granted to the manufacturer or processor.
(3) The authorisation shall be withdrawn if it subsequently becomes known that one of the grounds for the rejection pursuant to sub-section 1 sentence 3 existed at the time of the granting of the authorisation. The authorisation shall be revoked if one of the grounds for refusal developed subsequently, the suspension of the authorisation may be ordered instead of its revocation. The competent authority is entitled to prohibit the procurement of tissue or the laboratory testing temporarily if the removal establishment, the laboratory, the manufacturer or the processor fail to submit the necessary supporting documents for the procurement of tissue or the laboratory testing.
(4) Sub-sections 1 to 3 shall apply mutatis mutandis for the procurement and the laboratory testing of autologous blood for the manufacture of biotechnologically processed tissue products.
(5) The marketing authorisation holder shall notify the competent authority of every change in the prerequisites contained in sub-section 1 sentence 3 regarding the marketing authorisation, in advance, presenting the necessary evidence and may make the change only after receiving written permission to do so from the competent authority. In the case of an unexpected change in the appropriately qualified person pursuant to Section 20b, the notification shall be immediate.
Section 20c
Authorisation for the processing, preservation, testing and storage or the placing on the market of tissues or tissue preparations
(1) Any establishment that wishes to process, preserve, test, store or place on the market tissues or tissue preparations that are not processed using industrial procedures and the essential processing procedures of which are sufficiently well known in the European Union, requires, by way of derogation from Section 13 sub-section 1, an authorisation from the competent authority pursuant to the following provisions. This shall also apply to tissues or tissue preparations the processing procedures for which are new but comparable with a known procedure. The decision on whether to grant the authorisation shall be taken by the competent authority of the Land in which the facility is located or is to be located, in consultation with the competent higher federal authority.
(2) The authorisation may only be refused if:
1. a person with the necessary expert knowledge and experience pursuant to sub-section 3 (responsible person pursuant to Section 20c) responsible for ensuring that the tissue preparations and tissues are processed, preserved, tested, stored or placed on the market in keeping with the statutory provisions in force, is not available,
2. additional participating personnel is insufficiently qualified,
3. suitable premises and establishments are not available for the envisaged activities,
4. it is not guaranteed that the processing including the labelling, preservation and storage is conducted according to state-of-the-art scientific and technical procedures,
5. a quality management system pursuant to the principles of Good Practice has not been installed or has not been kept up to date, or
6. the responsible person pursuant to Section 20c or the applicant is not sufficiently reliable in the performance of his/her job.
By way of derogation from sentence 1 number 3, the testing of the tissues and tissue preparations may be conducted outside of the factory site, in commissioned factories which do not require an authorisation of their own, if suitable rooms and facilities are available there and if it is guaranteed that testing is conducted in keeping with the state of the art in science and technology and the responsible person pursuant to Section 20c is able to assume his/her responsibilities.
(3) Proof that the responsible person pursuant to Section 20c possesses the necessary expert knowledge, shall be provided by a certificate testifying to the successful completion of university studies in human medicine, biology, biochemistry or a course of studies considered equivalent as well as at least two years’ practical experience in the processing of tissues or tissue preparations. In the case of establishments that exclusively test tissue or tissue preparations, proof of practical experience pursuant to sentence 1 can also be provided in the form of at least two years’ practical experience in the in the processing of tissues or tissue preparations.
(4) Should there be any objections against the submitted documents, the applicant shall be given an opportunity to correct the flaws within an appropriate period of time. If the flaws are not corrected, the authorisation shall be refused. The authorisation shall be granted for a specific facility and for specific tissues or tissue preparations.
(5) The competent authority shall take the decision on the application for authorisation within a period of three months. Should the holder of an authorisation apply for a modification to the authorisation, the authority shall reach the decision within a period of one month. In exceptional cases, the deadline shall be extended by an additional two months. The applicant shall be notified thereof prior to the expiry of the deadline and notified of the grounds. If the authority gives the applicant pursuant to sub-section 4 sentence 1, the opportunity to correct the flaws, the deadlines shall be interrupted until such flaws have been corrected or until the expiry of the deadline set pursuant to sub-section 4 sentence 1. The interruption of the deadline shall begin on the day the applicant receives the request to correct the flaws.
(6) The holder of an authorisation shall notify the competent authority in advance of any change in the information referred to in sub-section 2 and shall submit evidence thereof; the changes may be made only after receipt of a written authorisation from the competent authority. Any unforeseen change in the responsible person pursuant to Section 20c shall be notified immediately.
(7) The authorisation shall be withdrawn if it becomes known subsequently that one of the grounds for refusal, pursuant to sub-section 2 existed at the time the authorisation was granted. The authorisation shall be revoked if one of the grounds for refusal developed subsequently, the suspension of the authorisation may be ordered instead of its revocation. Sub-section 1 sentence 3 shall apply mutatis mutandis. The competent authority may issue a provisional order mandating that the processing of tissues or tissue preparations be discontinued if the processor fails to furnish the evidence required for processing. If the processing of tissues or tissue preparations is terminated, the processor shall ensure that stored tissue preparations and tissues continue to be stored in a quality-assured manner and are transferred to other manufacturers, processors or distributors in possession of an authorisation pursuant to sub-section 1 or Section 13 sub-section 1. This shall also apply to the information and data about the processing which is necessary for the tracing of these tissue preparations and tissues.
Section 20d
Exception from the obligation to obtain an authorisation for tissues and tissue preparations
An authorisation pursuant to Section 20b sub-section 1 and Section 20c sub-section 1 shall not be required by a person who is a physician or otherwise authorised to practise medicine on human beings and who performs the activities mentioned therein, with the exception of the placing on the market, in order to use the tissue or tissue preparation personally on their patient. This shall not apply to medicinal products that are intended for clinical trials.
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