EN PL

News

FDA: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements

14.01.2011
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. FDA ...

EMA; Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work

05.01.2011
In accordance with Directive 2004/24/EC (1), amending as regards traditional herbal medicinal products, Directive 2001/83/EC, it is the task of the Committee on Herbal Medicinal Products (HMPC) to ...

EMA: Glossary on herbal teas

05.01.2011
The purpose of this paper is to define the terms applied to the preparation of herbal teas by patients. The definitions will help to clarify the terms used to describe the preparation of herbal ...

EMA: Scientific guideline: Reflection paper on the level of purification of extracts to be considered as herbal preparations

05.01.2011
This reflection paper applies to extracts used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for ...

Polish Ministry of Health: Regulation concerning reimbrusement of medicinal products and guaranteed benefits related to therapies.

29.12.2010
The package of regulations concerning registers of prices of medicinal product, medical devices and registers of basic and supplementary medicinal products. ...

Polish Ministry of Health: Regulation concerned GMP requirements

29.12.2010
Regulation concerning the Good Manufacturing Practice requirements and some changes related to this regulation. ...

EMA: Regulatory and procedural guideline: European Medicines Agency pre-submission procedural advice for users of the centralised procedure

29.12.2010
This guidance document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...

EMA: Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of hypertension

29.12.2010
Guidance is provided on the design of clinical studies considered to be of relevance for the evaluation of antihypertensive drugs. The current revision concerns fixed combinations in therapeutic ...

EMA: Herbal Medicinal Products: Leonurus, Leonuri cardiacae herba, Leonurus cardiaca L

29.12.2010
Community herbal monograph on Leonurus cardiaca L., herba; Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Leonurus cardiaca L., herba ; Overview of ...

EMA: Regulatory and procedural guideline: User guide for micro, small and medium-sized enterprises (SMEs) on the administrative and procedural aspects of the provisions, laid down in Regulation (EC) No 726/2004, that are of particular relevance to SMEs

29.12.2010
This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal ...