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Regulatory and procedural guidelines (human and veterinary)
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Last updated about 6 years ago
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
about 6 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
about 6 years ago
Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals
about 6 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
about 6 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)
about 6 years ago
Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management
about 6 years ago
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes
about 6 years ago