Manufacture of animal vaccines Permission
If you wish to manufacture immunological veterinary medicinal products within the meaning of section 11 paragraph 1 sentence 1 of the Animal Health Act (TierGesG) or in vitro diagnostics within the meaning of the 11 paragraph 2 sentence 1 TierGesG for the purpose of placing on the market, you need a permit for the respective remedy in accordance with Section 12 paragraph 1 TierGesG. If you wish to manufacture immunological veterinary medicinal products within the meaning of Section 11 paragraph 1 sentence 2 TierGesG ("Stock-Specific Vaccines") and in vitro diagnostics within the meaning of Section 11 paragraph 5 sentence 1,1 number 1 TierGesG for the purpose of placing on the market, you need a general authorisation not related to a specific immunological veterinary medicinal product or in vitro diagnostic in accordance with Paragraph 12 paragraph 2. The regulations on immunological veterinary medicinal products are excluded from its scope in accordance with Section 4a of the German Medicines Act (AMG) and are regulated in Sections 11 and 12 of the Animal Health Act as well as in the Animal Vaccine Ordinance. The main provisions for the manufacture, authorisation, supply, use or import of immunological veterinary medicinal products are regulated here. In addition, special requirements are applied to animals used for food production (including meat, milk, eggs). Regulation (EU) No 37/2010 is of particular importance here.
if necessary, extract from the commercial register Name of the permanent establishment (name, street, place) Site plans of the premises and premises for production, testing and storage if available, information on external establishments (also here addresses and site plans) Proof of the availability of the rooms Appointment of a competent person, as well as competent manufacturing and quality control manager in accordance with Section 5 TierimpfStV, with the indication of the personnel details of the production management, knowledgeable person, control management and/or sales management with date of birth, place of birth and address of the current place of residence as well as telephone reach, fax number and e-mail address Proof of the expertise required in accordance with Section 12 (4) TierGesG in conjunction with Section 5 TierImstV (in the original or by certified copy) and proof of the required reliability of the persons by means of certificates of management (in the original, not older than 3 months) Designation of the sales line with the name, telephone and fax number as well as e-mail address and proof of identity Proof of the persons responsible that the obligations in place can be fulfilled on a permanent basis Information on the planned manufacturing activities (products, processes, scope per year) or testing activities including manufacturing or testing procedures Designation of pharmaceutical and pharmaceutical forms, scope of manufacture and, where appropriate, processes where appropriate, information on the external establishments responsible for audits current "Site Master File" or description of the setup, quality assurance manual
Forms: no Online procedure possible: no Written form required: yes Personal appearance necessary: no
Regulation (EU) 2019/6 on veterinary medicinal products will enter into force on 28 January 2022, thereby repealing Directive 2001/82/EC. In connection with this, the current legal bases are also changing.
You can apply for a permit to produce animal vaccines in writing (informal): Submit the informal application with your exact name and address as well as information about the legal form and the necessary proofs to the LAVG. The LAVG then checks for the completeness of the documents and for your eligibility to apply. A inspection of the permanent establishment is carried out. Any defects discovered must be rectified. The LAVG then grants you the manufacturing permit. You will receive a fee notice from the LAVG to pay the fee for the issue of the manufacturing permit.
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Ministry of Social Affairs, Health, Integration and Consumer Protection
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