This page contains all manufacturer's licence application forms, including variations. It covers applications for products for human use and veterinary use.
| Manufacturer's licence forms - Products for human use - New applications |
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Manufacturer’s / importer’s licence (MIA) application form  (1482Kb) |
| Manufacturer's authorisation for investigational medicinal products (MIA(IMP)) application form (1377Kb) |
| Manufacturer "Specials" licence (MS) application form (1435Kb) |
Guidance Note 5: Notes for applicants and holders of a manufacturer's licence (364Kb) |
| Hospital exemption licence application form (1273Kb) |
| Manufacturer's licence forms - Products for human use - Variations to existing licences | |||
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| Fee calculation (59Kb) |
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| Forms to be used (52Kb) |
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| Where to send your variations (146Kb) |
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| Form 1V - Covering letter (175Kb) |
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| Form 2V - Basic company information (174Kb) |
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| Form 3V - Variation communications/invoicing address (173Kb) |
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| Form 9V - Variation to an existing site (551Kb) |
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| Form 10V - Variation to add a new site (463Kb) |
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| Form 11V - Variation to add a new Contract Laboratory site (216Kb) |
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| Form 12V - Variation to an existing Contract Laboratory site (225Kb) |
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| Form 13V - Variation to add a new Storage and Handling site (187Kb) |
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| Form 14V - Variation to an existing storage and handling site (188Kb) |
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| Manufacturer's licence forms - Products for veterinary use - New applications |
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| Note to holders of veterinary only licences (110Kb) |
| Veterinary Medicines Directorate: Guidance Notes (external link) |
| Manufacturer’s / importer’s authorisation (ManA) application form (1425Kb) |
| Manufacturer "Specials" authorisation (ManSA) application form (1432Kb) |
| Non-orthodox practitioners - Products for human use - New applications and variations to existing licences |
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| Covering letter - application for a non-orthodox practitioner authorisation (171Kb) |
| Application form: non-orthodox practitioner authorisation (196Kb) |
| Guidance Note 13: Manufacturer's licences authorising a non-orthodox practitioner to mix and assemble unlicensed medicinal products (72Kb) |
