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HMA: Additional legacy in Product Information

10.04.2009
Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors Hydrochlorothiazide and use during pregnancy ...

EDQM: New homoeopathic manufacturing methods for consultation

10.04.2009
The European Pharmacopoeia Commission has undertaken to introduce homoeopathic manufacturing methods into the European Pharmacopoeia. Methods 1 to 4 are already published in monograph 2371 Methods ...

MHRA: New guidance on consumer advertising for registered traditional herbal medicines

10.04.2009
The MHRA has developed advice for companies about the rules governing the advertising of registered traditional herbal medicines to consumers. The MHRA wants to help companies to work within the ...

MHRA: Guidance on changes to labelling and patient information leaflets for self certification: Inclusion of Braille on the labelling

10.04.2009
From 1 April 2009 compliance with article 56(a) of Council Directive 2001/83/EC may be achieved (in certain prescribed conditions) by means of a Better Regulation of Medicines Initiative (BROMI) ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (Annex 4A)

10.04.2009
International Conference on Harmonisation Regions
Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (Annex 4B)

10.04.2009
International Conference on Harmonisation Regions
Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (Annex 4C)

10.04.2009
International Conference on Harmonisation Regions
Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for ...

FDA: Q10 Pharmaceutical Quality System

10.04.2009
This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, ...

EMEA: User guide on how to generate PDF versions of the Product Information

10.04.2009
Revised PDF user guide for companies describing how to correctly generate PDF versions of the Product Information ...

EMEA: Status of EMEA guidelines and European Pharmacopoeia monographs in the regulatory framework

10.04.2009
The present guideline clarifies the status of EMEA scientific guidelines and European Pharmacopoeia monographs and chapters in the context of the regulatory framework applicable ...