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248. Regulation of the Federal Minister of Health on holdings producing, controlling or placing on the market the stock-specific vaccines for animals (stock-specific vaccines-Operating Regulations-BIBO)
On the basis of § 62 (1) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 146/2009, shall be ordered:
Scope
§ 1. (1) This Regulation shall apply to establishments which manufacture, control or place on the market of plant-specific vaccines for animals.
(2) Companies within the meaning of paragraph 1 shall apply to all establishments in the establishments covered by paragraph 1, even if they do not fall within the scope of the provisions relating to other establishments within the meaning of Section 46 of the Industrial Regulations 1994.
Definitions
§ 2. For the purposes of this Regulation:
1. |
vaccine: inactivated vaccine produced using a pathogen isolated from a given herd or an animal, and used only in that herd or animal; |
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2. |
Operating room: any room in which stock-specific vaccines are manufactured, controlled or stored; |
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3. |
Manufacture: the winnings, the preparation, the preparation, the processing, the refilling, including the filling, the packaging of the stock-specific vaccines as well as the identification; |
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4. |
Manufacturer: all persons involved in manufacturing activities according to Z 3, for which a corresponding authorization is required in accordance with Section 63 (1) of the Medicines Act; |
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5. |
Reference sample: a sample of a batch of packaging material or vaccine stored for the purpose of analysis and identification. |
Operational Organization, Staff
§ 3. (1) Each establishment must have sufficient numbers of qualified and qualified staff.
(2) Each establishment shall draw up an organisation scheme with a clear indication of the internal tasks and responsibilities of the company, which must be up-to-date in operation.
(3) The tasks of the employees in a senior or responsible position must be defined in job descriptions.
(4) The organisation scheme and job descriptions shall be approved according to internal procedures.
(5) The staff referred to in paragraph 3 shall be given sufficient powers and shall be provided with all necessary means and information to enable them to fulfil their responsibilities and carry out their duties.
(6) Each establishment must operate an effective and functional quality assurance system in accordance with the nature and extent of the activity carried out, which shall ensure the active participation of the management and the staff of the individual affected areas.
(7) The staff must be trained in accordance with an approved training programme prior to the start of the work and thereafter on an ongoing basis.
(8) The efficient implementation of training must be regularly assessed. The training shall relate in particular to the theory and application of the quality assurance system. The training measures must be documented.
(9) In each establishment, a hygiene programme must be established which, according to the scientific state of the art, must be adapted to the requirements of the production of the vaccine carried out during operation and must be designed in such a way as to ensure that adverse external effects, In particular, contamination and germs, premises, equipment, vaccine or packaging material are avoided.
Manufacturer/Production Manager
§ 4. (1) For each establishment in which stock-specific vaccines are produced, a head of manufacture/production manager shall be ordered.
(2) The Head of Production/Production Manager shall:
1. |
in a Contracting Party of the European Economic Area (EEA) or in Switzerland, a study of veterinary medicine, human or dental medicine, biology, microbiology or pharmacy has been successfully completed, and |
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After that, at least two years of qualified manufacturing activity in a contracting party of the EEA or in Switzerland in the field of veterinary microbiology |
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a) |
at a university, or |
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b) |
in a state-authorized or approved private microbiological laboratory, or |
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c) |
in one or more undertakings which have been granted an authorization to manufacture veterinary vaccines and sera, |
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have been exercised. |
(3) Insofar as the ready-in-inactivated stock-specific vaccines are only bottled, packaged or marked in one operation, the theoretical and practical qualification of a manufacturer of the production manager according to § 8 of the Drug Operating Regulations 2009, BGBl. II No 324/2008, sufficient.
(4) In particular, the Head of Production shall be responsible for:
1. |
ensuring that the specific vaccines are produced and stored in accordance with the appropriate instructions in order to obtain the required quality, |
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the approval of the instructions for the production operations and the assurance that they will be strictly adhered to, |
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the control of the premises and equipment and the control of the necessary maintenance; |
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to ensure that the necessary validations are carried out, and |
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ensuring that the necessary initial and continuous training of personnel is carried out and adjusted according to the respective requirements. |
(5) A personnel union of head of manufacture/production manager and control laboratory head/control laboratory head is not permitted.
Control laboratory head/control laboratory head
§ 5. (1) For each establishment in which inventory-specific vaccines are manufactured or controlled or in which packaging material is controlled, a control laboratory manager shall be ordered to appoint a control laboratory.
(2) The Head of Control shall be responsible for the control laboratory
1. |
have successfully completed a degree in veterinary medicine, human or dental medicine, biology, microbiology or pharmacy in one of the parties to the EEA or in Switzerland, or have successfully completed a technical college of applied sciences in this field, and |
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after that, an at least two-year qualified inspection activity in a contracting party of the EEA or in Switzerland in the field of veterinary microbiology |
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a) |
at a university, or |
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b) |
in a state-authorized or approved private microbiological laboratory, or |
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c) |
in one or more undertakings which have been granted an authorisation to control veterinary vaccines and sera, |
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have been exercised. |
(3) In the case of other subject-related training in a Contracting Party of the EEA or in Switzerland, other than those referred to in paragraph 2 (1) (1), a qualified activity of at least five years in accordance with paragraph 2 (2) (2) (2) shall be completed after successful completion is required.
(4) Insofar as the finished inactivated residue-specific vaccines are only bottled, packaged or labelled in one operation, the theoretical and practical qualification of a control laboratory manager according to § 9 shall apply. of the Medicines Operating Regulations 2009.
(5) In the course of the technical assessment, the control laboratory manager must be independent in the course of the tests to be carried out by other organisational units of the holding. It may not be entrusted with tasks that are to be performed by other organizational units of the company.
(6) In particular, the control laboratory manager shall be responsible for:
1. |
to ensure the evaluation of the protocols for the production and testing of the individual batch-specific vaccine batches; |
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ensuring that all necessary tests are carried out, |
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3. |
the granting of the marketing authorisation for stocks-specific vaccines or the packaging material; and |
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4. |
the rejection of any stock-specific vaccines or packaging material. |
(7) A personnel union of control laboratory head/control laboratory head and head of manufacture/production manager shall not be permitted.
Operating rooms, equipment, cleaning
§ 6. (1) The premises must be in a proper physical and hygienic condition and must be suitable for the work to be carried out in the establishment and be present in sufficient numbers, so that the state of the scientific community shall be and technology for the production, control or storage of stock-specific vaccines. Separate operating rooms must be provided for each production step and the storage of stock-specific vaccines. Such measures shall be protected by appropriate measures to prevent the access of unauthorised persons.
(2) The operating rooms must be dedicated to a particular purpose. The production and control of stocks-specific vaccines must be spatially separated from other manufacturing stages and from veterinary activities. Operating rooms must not be used in a dedicated way. The intended use of the individual operating rooms shall be defined in a spatial plan plan which must be in operation.
(3) The operating rooms shall be arranged in such a way as to ensure an orderly, clear and smooth operation of all operations. All work with live, animal pathogenic germs are carried out in a laboratory according to the provisions of the Regulation biological agents (VbA), BGBl. II No 237/1998, in each case, at least in the security level 2. The filling of the stock-specific vaccines must be carried out in a sterile workbench corresponding to the state of science and technology. The various batches are to be processed spatially or temporally separately.
(4) The lighting, heating, ventilation and air-conditioning of the premises must meet the requirements of the operations to be carried out and the quality requirements of the vaccines. If the air is recirculated for operating rooms which are used for production, special measures shall be taken to prevent contamination or cross-contamination.
(5) The equipment and other operating and auxiliary equipment must be suitable for the work to be carried out in each case and must be present in sufficient numbers, so that a production corresponding to the state of the art and technology is available, Control or storage of stock-specific vaccines is guaranteed.
(6) The design of the equipment must ensure that it is easy to clean and to keep clean. The equipment shall be waiting at reasonable intervals.
(7) Where necessary for the safety of the stock-specific vaccines, the equipment or parts thereof may only be used in a sterilized condition.
(8) The operating rooms and equipment must be designed in such a way that:
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a thorough cleaning and maintenance is possible, |
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errors and error risks are kept as low as possible; and |
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Contamination, cross-contamination and, more generally, any effect affecting the quality of the vaccine will be avoided. |
Hygiene programme
§ 7. (1) The hygiene programme referred to in Article 3 (9) shall at least contain:
1. |
Provisions relating to the health of staff and instructions on the hygiene behaviour of personnel in the manufacture, control and storage of stock-specific vaccines or packaging materials, as well as information on the use of the working or protective clothing, |
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Instructions on the cleaning and disinfection measures to be carried out, their frequency and the equipment and tools to be used, |
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particulars of persons responsible for cleaning or disinfection and those responsible for the proper conduct of those activities; |
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information on the permitted levels of microbial and particulate contamination of the air in the filling area of the vaccines, and instructions on the time intervals in which measurements are to be carried out in this regard, |
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instructions for combating an infestation with animals, in particular rodents and insects, including information on the authorising officers responsible for the fight against them and responsible for the proper conduct of those activities, In any case, written instructions must include the use of rodenticides, insecticides, fungicides, gassing agents, cleaners and disinfectants, and |
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Instructions for the management of waste water, waste and other residues in and out of the operating rooms, including information on the disposal of the waste and responsible for the proper conduct of those activities authorizing persons. |
(2) The measures taken to comply with the hygiene programme shall be kept in keeping with the records kept in operation.
Manufacture
§ 8. (1) In the production of specific vaccines, the Head of Production/Production Manager shall ensure that only such standard methods are used which correspond to the current state of science and technology. The validation of the production of individual stock-specific vaccines can be carried out jointly for a number of substances prepared in the same way.
(2) The individual manufacturing steps must be carried out in accordance with previously prepared written instructions and process descriptions (preparation instructions). Time limits or value limits should be set for the end of each manufacturing step.
(3) The vaccines may only be auxiliaries and additives referred to in Article 14 (2) (lit). (c) Regulation (EC) No 470/2009 establishing a Community procedure for the establishment of maximum residue limits of pharmacologically active substances in foodstuffs of animal origin.
(4) substrates and media for production must comply with the requirements of the monograph "vaccines for animals" of the European Pharmacopoeia.
(5) By way of derogation from paragraph 4, starting materials and containers which are not described in the European Pharmacopoeia may be used in individual cases for the production of stock-specific vaccines. The use of such starting materials and containers shall be scientifically justified in the context of the records.
(6) Where formaldehyde or phenol is used for the production of the vaccine, the maximum levels of the maximum residue level of the vaccine specified in the European Pharmacopoeia monograph "Vaccines for animals" may not be exceeded.
(7) The necessary technical and organisational measures need to be taken to avoid contamination and confusion. The measures for the prevention of contamination and their effectiveness shall be reviewed at regular intervals in accordance with established procedures.
(8) Before each processing operation, it is necessary to ensure that the work area and equipment are clean and free of all the starting materials, products, product residues or documents which are not required for the planned operations.
(9) The implementation of weighing operations shall always be confirmed by a second person or shall be recorded by a validated automated procedure.
(10) adequate and sufficient resources must be made available for the implementation of the in-process controls.
(11) protective clothing must be worn and cleaned regularly. Equipment, equipment and other objects used for the manufacture of specific vaccines shall be cleaned and disinfected, in each case, after use.
(12) The waste arising from the production of specific vaccines must be destroyed or treated in such a way that they cannot cause any health hazards before they are removed from the holding.
Risk Analysis
§ 9. Establishments producing or controlling stocks-specific vaccines must set up a procedure based on the following principles:
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identification of risks to be avoided or to be reduced to an acceptable level; |
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determination of the critical control points at the process stages on which control is necessary in order to avoid a risk or to reduce it to an acceptable level, |
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Establish and implement efficient procedures for monitoring critical control points, |
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the establishment of corrective measures in the event that the monitoring shows that a critical control point is not under control; and |
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Preparation of records appropriate to the nature and size of the entire scope of the holding, in order to demonstrate that the measures referred to in Z 1 to 4 are used for the production of specific vaccines. |
Quality control
§ 10. (1) establishments producing or controlling the level of specific vaccines must have a quality control plan, which must be in writing in writing. It shall include, in particular, controls on the premises, the manufacturing process, equipment, materials, personnel and documentation.
(2) Reference samples of each batch shall be kept for at least one year from the date of the decay of the batch concerned, as provided for in the state of science and technology.
(3) The period of shelf-life of stock-specific vaccines must be defined and regularly reevaluated. The maximum shelf-life period is six months from the date of bottling.
(4) Inventory-specific vaccines must be subjected to a sterility test prior to filling, which must be documented in the manufacturing protocol.
(5) Holders have to regularly check reference samples of stock-specific vaccines with the state of the scientific community, up to the date of the decay, to a reasonable extent for purity and harmlessness. The results of the tests shall be recorded and shall be submitted immediately upon request to the Federal Office for Safety in the Health Care Sector.
(6) The Federal Office for Safety in Health (Bundesamt für Sicherheit im healthcare) shall immediately inform the Federal Office of Health of a reference sample of a charge on the market that it does not meet the requirements with regard to purity or harmlessness.
Marking
§ 11. (1) The labelling of stocks-specific vaccines shall be marked on the container in clearly legible writing and in a durable manner and shall contain the following:
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the name of the specific vaccine, |
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the reference to 'stock-specific vaccine', |
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Active ingredients according to the type or pharmaceutical form referred to a specific volume or weight, |
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the name of the manufacturer, |
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The name of the prescribing veterinarian, |
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the name of the holder of the holder or of a reference number which is clearly assigned to the holder and to the individual prescription; |
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the nature of the application, |
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"Wait 0 days" |
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"subject to prescription" or "receptive", |
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Land-use content, |
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batch number, |
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Expiry date, |
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storage conditions, and |
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Shelf-life after initial opening/opening of the container. |
(2) In the case of the delivery of vaccine specific vaccines to the veterinarian, a cover letter shall be submitted to the veterinarian, containing at least:
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the name and address of the manufacturer; |
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the name of the specific vaccine, |
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Active ingredients according to the type or pharmaceutical form referred to a specific volume or weight, |
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the pharmaceutical form, |
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fields of application, |
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contra-indications, |
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Adverse reactions, |
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Interactions with other medicinal products and other forms of interaction, |
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Target species and limitations of the application, |
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Dosage and method of administration, |
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the period of application, |
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details of the waiting period, |
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storage conditions, |
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Special warnings, and |
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Special precautions for use. |
Documentation
§ 12. (1) Unless otherwise provided for the retention of records, reports or documents, the documents shall be kept in use for at least five years from the last dated signature.
(2) The documents shall be clear, clear, complete and up-to-date. Any change in an entry in a document must be signed, justified and dated. Despite the change, the original information must remain legible. If displayed, the reason for the change must be documented.
(3) If data are recorded not in writing but with electronic, photographic or other data processing systems, detailed descriptions of the procedures relating to the system used shall be drawn up. Written records must be kept in operation after the respective equipment or computer and computer system have been out of service and in accordance with the EDP system.
(4) Each operation must demonstrate that the data are properly stored during the expected retention period. The data stored with such systems must be made available at all times in a readable form and must be submitted to the Federal Office for Health Security on request. Electronically stored data must be protected against data loss or damage by means of measures such as duplication or back-up and transfer to another storage system. These measures must be documented in a comprehensible manner.
(5) establishments which produce or control specific vaccines must be accompanied by appropriate documentation, including a system for the preparation, revision and approval of documents, by appropriate and competent authorities. Persons in possession of compliance with the quality control plan, hygiene programme and quality assurance system.
(6) establishments producing stock-specific vaccines shall have a production protocol from each batch, which shall include the results of the in-process controls and which shall be annexed to the cover letter in accordance with Article 11 (2).
(7) holdings that produce evidence-specific vaccines shall keep records of the exact origin of the pathogens and on their submission, the evidence of which shall be clearly identified by the recipient of the vaccine. -to ensure that the vaccines are subject to specific conditions.
(8) holdings bringing stock-specific vaccines into circulation shall keep records ensuring the traceability of each batch of a stock-specific vaccine placed on the market.
Audit specification, audit trail
§ 13. (1) For each examination to be carried out under the responsibility of the control laboratory head, a test procedure corresponding to the respective state of the scientific community must be up and down and must be subject to all persons involved in the examination during the course of the examination. their activity is constantly available. The inspection procedure must be approved by the control laboratory head by the control laboratory.
(2) Any modification of the test specification shall be carried out in accordance with the requirements of the quality assurance system.
(3) Any checks or tests carried out in accordance with the test procedure shall be documented without delay, and a record shall be drawn up at the earliest opportunity, which shall clearly identify the results of any checks or tests which are based on the and include a summary assessment. The inspection protocol must be confirmed by the control laboratory head with the date and signature.
Maintenance and calibration program
§ 14. A maintenance and-if necessary for vaccine safety-calibration program, which has to contain written instructions on the maintenance, calibration and inspection of equipment including accessories and tools, shall be prepared and to keep it in use. In particular, the instructions shall include:
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Determination of responsibility for maintenance and calibration, |
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maintenance and calibration plans; and |
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a detailed description of the methods, equipment and materials used for the maintenance and calibration procedures, as well as a description of how the equipment is dismantled and assembled, to the extent that this is necessary for maintenance and Calibration is required. |
Storage and transport
§ 15. (1) Storage and transport of stock-specific vaccines shall be carried out under conditions corresponding to the state of the art and technology, in particular in such a way as to avoid confusion or contamination and no change in quality and effectiveness.
(2) Inventory-specific vaccines shall be stored separately from other products and shall be stored in such a way as to ensure that their quality and effectiveness are not impaired.
(3) All deliveries of stocks-specific vaccines must be accompanied by documents containing at least the following information:
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the date of delivery, |
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the name of the specific vaccine, |
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batch number, |
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quantity delivered, |
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the name and address of the supplier of the isolated pathogen; and |
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Name and address of the recipient of the vaccine. |
(4) The vessels or containers for the inclusion of stocks-specific vaccines must be made of a material corresponding to the specific nature of the product to be stored, and must not adversely affect the quality and efficacy of the vaccine. Product.
Complaints and product recall
§ 16. In the case of specific vaccines, each establishment must have a system in order to systematically record and check complaints and to take effective systematic arrangements to ensure that the products are at all times rapid can be recalled. The holding shall record and investigate any complaint lodged by a defect. The Federal Office for Safety in Health shall immediately inform the Federal Office of Health of any defect that may result in a recall or an unusual restriction on the distribution of the product.
Stöger