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- Organisation Management Service (OMS) | Medicines Evaluation Board
The European Medicines Agency (EMA) has established the Organisation Management Service (OMS) to support regulatory activities in the entire European Union The OMS manages master data for one of the four domains – substance, product, organisation and referential (SPOR) – in the context of pharmaceutical regulatory processes
- Veterinary Medicinal Products Regulation: QRD template, GMP . . .
More information about the OMS EMA activities: webinar and second veterinary medicines info day EMA FVE webinar about data collection about sale and use of antimicrobial agents - 24 November 2021, 14 00-15 30 hours; Second veterinary medicines info day - 30 November 2021, 10 00-17 00 hours
- Veterinary Medicinal Products Regulation: link between EudraGMDP . . .
A number of things are going to change in relation to the EudraGMDP database in the field of veterinary medicinal products This is a consequence of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019 6), which is coming into effect on 28 January 2022 For example, the database will be linked to the EMA's OMS system, which is used to link data on marketing authorisation holders
- Database for manufacturing and wholesale distribution (EudraGMDP) - CBG MEB
oms You must register in the Organisation Management Service (OMS) -database of the European Medicines Agency (EMA), otherwise we, as the Veterinary Medicinal Products Unit (BD), cannot process your manufacturing license or certificate (MIA), your wholesale license (WDA), or your registration for the veterinary raw materials register in this database
- Manufacturing (F) (GMP) | Medicines Evaluation Board - CBG MEB
oms An organisation must have registered with the Organisation Management Service (OMS) database of the European Medicines Agency (EMA) If not, the Veterinary Medicinal Products Unit cannot process the manufacturing licence or certificate (MIA GMP), the wholesale licence (WDA) or the registration for the veterinary starting materials register in the European database (EudraGMDP)
- Latest | Medicines Evaluation Board - CBG MEB
Veterinary Medicinal Products Regulation: QRD template, GMP certificates, OMS registration and EMA activities The entry into force of the Veterinary Medicinal Products Regulation ( Regulation (EU) 2019 6) on 28 January 2022 will result in News item | 24-11-2021 | 12:00 Newest issue of Regulatory Science Magazine
- Latest | Medicines Evaluation Board
Veterinary Medicinal Products Regulation: QRD template, GMP certificates, OMS registration and EMA activities The entry into force of the Veterinary Medicinal Products Regulation ( Regulation (EU) 2019 6) on 28 January 2022 will result in News item | 24-11-2021 | 12:00 Newest issue of Regulatory Science Magazine
- Licence requirements for wholesale (G) | Medicines Evaluation Board
oms You must register in the Organisation Management Service (OMS) -database of the European Medicines Agency (EMA), otherwise we, as the Veterinary Medicinal Products Unit (BD), cannot process your manufacturing license or certificate (MIA), your wholesale license (WDA), or your registration for the veterinary raw materials register in this database
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