Regulatory and procedural guidelines (human and veterinary)

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

over 5 years ago

The guideline, which was developed to encourage optimal use and to minimise...

Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals

over 5 years ago

Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals

over 5 years ago

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

over 5 years ago

This report provides a final agreed draft Context of Use for public...

Regulatory and procedural guideline: Member states contact points for translation review (v.6.11)

over 5 years ago

Regulatory and procedural guideline: Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a m

over 5 years ago

Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management

over 5 years ago

Regulatory and procedural guideline: IRIS quick guide to registration version 1.3

over 5 years ago

Regulatory and procedural guideline: Dates of 2019 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests

over 5 years ago

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes

over 5 years ago

Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

over 5 years ago

Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets

over 5 years ago