EN PL

News

FDA: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

02.10.2009
This guidance applies to certain drug and biological products submitted for approval or approved under sections 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA), or section 351 ...

MHRA: Detailed Description of the Pharmacovigilance System for Parallel Imported Products

30.09.2009
There are a small number of instances where a parallel importing company is required to take on responsibility for pharmacovigilance. Examples of such instances include: when the UK reference ...

European Commission: Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (Revision 17 – September 2009)

30.09.2009
Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (Revision 17 – September 2009) ...

EMEA: Community herbal monograph

30.09.2009
Community herbal monograph on Absinthii herba Artemisia absinthium L., herba (wormwood herb) ...

EMEA: Guideline on the change of classification of veterinary medicinal products authorised by the community

30.09.2009
This guideline applies only to centrally authorised veterinary medicinal products and concerns changes in classification from prescription-only to non-prescription for veterinary medicinal ...

EMEA: Substances considered as not falling within the scope of the MRL Regulation

30.09.2009
This document supersedes the List of Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90 (EMEA/CVMP/046/00-Rev.16), and was adapted to take account of the ...

HMA: CMD(h) Best Practice Guide on the use of eCTD in the MRP/DCP

30.09.2009
Further to experience gained both by Industry and National Competent Authorities, the CMD(h) has developed guidance to facilitate the use of eCTD as the submission format in the MRP and DCP. This ...

HMA: Requests to act as RMS in DCP

30.09.2009
Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures. ...

EMEA: Questions and answers on the review of bisphosphonates and the risk of osteonecrosis of the jaw

28.09.2009
The European Medicines Agency has completed a review on the risk of osteonecrosis (death of bone tissue) of the jaw associated with the use of bisphosphonates. The Agency’s Committee for ...

European Commission: Implementation of the Advanced Therapies Regulation

24.09.2009
Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use ...