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Scientific guidelines (human and veterinary)

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Last updated about 16 hours ago

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1

about 17 hours ago

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems...

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Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1

4 days ago

Guideline on data requirements for changes to the strain composition of authorised...

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Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products

4 days ago

Concept paper on the quality and safety aspects of RNA interference and...

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Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)

4 days ago

Concept paper on the revision of the guideline on pharmaceutical fixed combination...

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Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1

4 days ago

Guideline on data requirements to support in-use stability claims for veterinary vaccines...

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Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1

6 days ago

Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04...

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Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products

13 days ago

Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal...

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Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum

13 days ago

Concept paper on the revision of the guidelines on Good Manufacturing Practice...

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Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

14 days ago

Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance...

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Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children

about 1 month ago

Guideline on the clinical evaluation of medicinal products for weight management -...

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Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin

about 1 month ago

Concept paper on the revision of the guideline on data requirements for...

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Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)

about 1 month ago

Concept paper on the revision of the guideline on data requirements for...

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Scientific guidelines (human and veterinary)

Latest posts

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1

Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with WOAH recommendations - Revision 1

Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products

Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)

Guideline on data requirements to support in-use stability claims for veterinary vaccines - Revision 1

Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1

Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products

Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation - Corrigendum

Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children

Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin

Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)

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