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Success in the marketing authorisation and post-marketing authorisation of veterinary medicinal products: BgVV has exceeded targets for 2001

02/2002, 08.02.2002

Health protection for the population and planning reliability for the pharmaceutical entrepreneur

BgVV is making good progress with the marketing authorisation and post-marketing authorisation of veterinary medicinal products pursuant to the German Drugs Act (AMG). In 2001 the Institute completed 86 procedures for the marketing authorisation of new veterinary medicinal products. Around one-fifth of the marketing authorisations were issued in conjunction with the mutual recognition procedure of the EU Member States (decentralised procedure), the others on the basis of the national marketing authorisation procedure. A final decision on all applications was made within the statutory period of seven months. In some cases, processing was considerably shorter than the admissible processing time. For the pharmaceutical entrepreneur this means more planning reliability because he can expect to receive a notice within the stipulated period and, if marketing authorisation is granted, begin marketing his medicinal products. Marketing authorisation is only issued if all documents are submitted and the statutory requirements are met in terms of quality, efficacy and safety.

BgVV has also made major progress in the prolongation procedure, called "post-marketing authorisation" of what up to now had only been "fictitiously" authorised medicinal products. Existing medicinal products are all medicinal products which were on the market prior to the entry into force of the German Drugs Act in 1978. They must be examined within the framework of "post"-marketing authorisation according to the provisions of the German Drugs Act (AMG). In 2001 a total of 1,018 procedures was concluded. Given the special urgency priority was given above all to antibiotics and, in particular, to those which are used as pharmaceutical premixes in the production of feed-based veterinary medicinal products. In the interests of consumer health protection, BgVV is especially thorough and cautious in respect of their post-marketing authorisation. Applications with any unsubstantiated combinations or inadequate dosage regimens are rejected in order to counteract as far as possible the emergence of resistances in livestock. This procedure makes foods safer and gives the consumer even better protection. It also serves the purposes of animal welfare when antibiotics retain their efficacy. The current personnel and structural preconditions should guarantee the timely conclusion of post-marketing authorisation in 2005.

Applications for veterinary medicinal drugs processed by BgVV in 2001:

Type of procedure

Total

Of which authorisations

Of which refusals/
withdrawals

Of which cancellations/
withdrawals

National
procedure

74

46

24

 

Decentralised
EU procedure

12

12

 

 

Post-authorisations
pursuant to § 105
German Drugs Act AMG

1018

101

36

881

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