IMB Newsletter Issue No. 35 January - April 2010
18 June 2010
Download: IMB Newsletter Issue No. 35 January - April
General
New Variations Regulation
Human Medicines
- Guidance for Marketing Authorisation Holders on Direct Healthcare Professional Communications – Publication of National Guidance
- Transfers of Product Authorisations and Parallel Product Authorisations for Human Medicines
- Herbal Medicinal Products – Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007) and (Amendment) Regulations 2009 (S.I. No. 3 of 2009)
- Recommendations for labelling of peel-off blisters
- National Rules Scheme for Homeopathic Medicines
Veterinary Medicines
- Collection of information on the use of veterinary antimicrobial agents
- Guide to the Decentralised and Mutual Recognition Procedures for Veterinary Medicinal Products using Ireland as RMS
- Font size on Product Literature
- Submission of mock ups following the completion of procedures
- Possible revision to the EU Directives governing the authorisation of veterinary medicinal products
- Type IA and foreseen Type IB variation applications
Compliance
- GMP and Market Compliance Information Day 2010
- Certification of MA Compliance
- New IMB Contact Information for Reporting Quality Defects, Product Recalls and Emergency Situations regarding Medicinal Products to the IMB
- Important Note Concerning the IMB’s Sampling and Analysis Programme
- Update on the IMB Cosmetic Project