APPLICATIONS PAGE

APPLICATION FORMS & RELATED CHECKLISTS

 

National

European

Manufacturers and Wholesale Dealers

NATIONAL:
	PDF	Word
New
Marketing Authorisation	Open	Open
Exceptional Marketing Authorisation	Open	Open
Variation
National Variation	Open	Open
UK Annex to Application for Variation to a Marketing Authorisation	Open	Open
Renewal
First Renewals:
Mutually recognised products	Open	Open
Nationally authorised products	-	Open
Data requirements for renewals on nationally authorised products	-	Open
Second/Subsequent renewals (applicable to nationally authorised products only):
Application form	-	Open
Declaration	-	Open
Animal Test Certificates - ATCs
Pharmaceutical Application	Open	Open
Immunological Application	Open	Open
Variation Application	Open	Open
Label Proforma for ATCs	Open	-
ATC (s) Scheme	Open	Open
Import
Special Treatment Certificate	Open	Open
Special Import Certificate	Open	Open
Wholesale Dealer Import Certificate	Open	Open
Parallel Import Marketing Authorisation	Open	Open
Others
Autogenous Vaccines	Open	Open
Autogenous Vaccine Variation	Open	Open
Homeopathic Veterinary Remedy	Open	Open
Non-Food Animal Blood Bank	Open	Open
Request for Specific Batch Control (formerly Specific Batch Exemptions)	Open	Open
Equine Stem Cell Centre	Open	Open
Checklists
Tabular Formats for the Safety Expert Report	Open	-
Tabular Formats for the Pharmaceutical Expert Report	Open	Open
Summary of Information on Residues Depletion	Open	Open
User Risk Assessment for Pharmaceutical & Feed Additive Marketing Authorisations	Open	Open
Validation Checklists
Validation Tick Box Lists are used by the VMD assessors, prior to the commencement of the assessment, to ensure that an application dossier is complete and is in accordance with the Notice to Applicants. After the recent joint VMD/NOAH seminar, Industry expresses an interest in seeing the validation check lists used by the assessors. Copies of the check lists used by the various disciplines in respect of pharmacuetical and immunological products are now available and may be downloaded.
Drug Master File	Open	-
Full Marketing Authorisation	Open	-
Extension	Open	-
Animal Test Certificate Type A	Open	-
Animal Test Certificate (other than Type A)	Open	-
Marketing Authorisation Immunological Validation	Open	-
Marketing Authorisation Parallel Import	Open	-
Provisional Marketing Authorisation Immunological Validation	Open	-
Renewal Marketing Authorisation Immunological Validation	Open	-
Animal Test Certificate Immunological Validation	Open	-
Variation Validation	Open	-
EUROPEAN:
	PDF	Word
Variation
s
Variation to a European Marketing Authorisation	Open	Open
UK Annex to Application for Variation to a Marketing Authorisation	Open	Open
Renewal
Renewal of a European Marketing Authorisation	Open	Open
Manufacturers and Wholesale Dealers:
	PDF	Word
Manufacturers Authorisations	Open	Open
Wholesale Dealer's Authorisation	Open	Open
Wholesale Dealer's Authorisation Variation	Open	Open
Manufacturers "Special" Authorisation	Open	Open
Schedule 6 Manufacturers Authorisations	Open	Open
Feedingstuffs, Manufacturers & Distributors
Feedingstuffs Manufacturers	Open
Feedingstuffs Distributors	Open
SQP Retailers
SQP Retailers	Open
			Back to top

If you have any problems with the site please contact the webmaster