Leistungen A-Z

Forms: no

Online procedure possible: no

Written form required: yes

Personal appearance required: no

If you want to manufacture immunological veterinary medicinal products within the meaning of Section 11 (1) sentence 1 of the Animal Health Act (TierGesG) or in vitro diagnostics within the meaning of Section 11 (2) sentence 1 of the Animal Health Act for the purpose of placing them on the market, you need a licence for the respective product in accordance with Section 12 (1) of the Animal Health Act.

If you wish to manufacture immunological veterinary medicinal products within the meaning of Section 11 (1) sentence 2 TierGesG ("Stock-specific vaccines") and in vitro diagnostic medical devices within the meaning of Section 11 (5) sentence 1 number 1 TierGesG for the purpose of placing them on the market, you need a general authorisation in accordance with Section 12 (2) that does not relate to a specific immunological veterinary medicinal product or in vitro diagnostic device.

According to § 4a of the German Medicines Act (AMG), the regulations on immunological veterinary medicinal products are excluded from its scope of application and are regulated in the Animal Health Act in §§ 11 and 12 as well as in the Animal Vaccine Ordinance.

The most important 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 that are used for food production (including meat, milk, eggs). Regulation (EU) No 37/2010 is of particular importance here.

• If applicable, excerpt from the commercial register
• Name of the permanent establishment (name, street, town)

• Site plans of the company buildings and operating rooms for production, testing and storage
• if available, information on external business premises (also here addresses and site plans)
• Proof of availability of the rooms
• Designation of a competent person, as well as a competent production and quality control manager in accordance with § 5 TierimpfStV, stating personal details of the production management, qualified person, control management and/or sales management with date of birth, place of birth and address of current residence as well as telephone availability, fax number and e-mail address
• Proof of the expertise required in accordance with § 12 paragraph 4 TierGesG in conjunction with § 5 TierImpfStV (in the original or by certified copy) as well as proof of the required reliability of the persons by means of certificates of good conduct (in the original, not older than 3 months)
• Designation of the sales manager, stating the name, telephone and fax number as well as e-mail address and proof of identity
• Evidence from the responsible persons that the obligations incumbent can be fulfilled at all times
• Information on the planned manufacturing activities (products, processes, scope per year) or testing activities including the manufacturing or testing methods
• Names of medicinal products and pharmaceutical forms, scope of manufacture and, where appropriate, procedures
• where applicable, details of the external undertakings responsible for carrying out inspections;
• Current "Site Master File" or description of the institution, quality assurance manual

Fee for the issuance of the manufacturing authorization: EUR 150.00 – 5,000

You must apply for a permit to manufacture animal vaccines in writing (informally):

• Submit the informal application with your exact name and address as well as information on the legal form together with the necessary evidence to the LAVG.
• The LAVG will then check for the completeness of the documents and your eligibility to apply.
• An acceptance inspection of the premises is carried out.
• You must remedy any defects that may have been discovered.
• The LAVG will then grant you the manufacturing authorization. You will receive a fee notice from the LAVG to pay the fee for the issuance of the manufacturing authorisation.

Application deadline: complete submission to the LAVG at least 3 months before the planned start of the manufacturing plant

State Office for Occupational Safety, Consumer Protection and Health (LAVG)

State Office for Occupational Safety, Consumer Protection and Health (LAVG)

Department "Consumer Protection", Department V2

Von-Schön-Str. 7

03050 Cottbus

Phone: 0331-8683540

Fax. 0331-275484257

Service hours:

Mon 09:00 a.m. - 03:00 p.m.

Tuesday 9:00 a.m. - 3:00 p.m.

Wed. 09:00 a.m. - 03:00 p.m.

Thursday 9:00 a.m. - 3:00 p.m.

Friday 09:00 a.m. - 03:00 p.m.

• §§ 11 and 12 of the Animal Health Act (TierGesG)
• §§ 2 to 10 Animal Vaccine Ordinance (TierImpfStV)
• §§ 2, 4, 5 and 7 to 9 of the Ordinance on Epizootic Pathogens (TierSeu-chErV)

On 28 January 2022, Regulation (EU) 2019/6 on veterinary medicinal products enters into force, repealing Directive 2001/82/EC. In connection with this, the currently valid legal bases are also changing.

• Competent authorities on the homepage of the Central Office of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG)

Ministry of Social Affairs, Health, Integration and Consumer Protection