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

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

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

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

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

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

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 ...

European Commission: Public consultation of the revised chapter 5 of the GMP laying down the detailed guidelines for production

This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for ...

HMA: Requirements on electronic submissions for Renewals & Variations within MRP, DCP or National procedures

Most NCAs are now ready to receive electronic-only applications and applicants are therefore strongly encouraged to submit in electronic format (eCTD or NeeS) to these NCAs, even if many still ...

EMA: Scientific guideline: Concept paper on revision of: Note for Guidance on the Clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00), draft

Subcutaneous and intramuscular immunoglobulin (SCIg/IMIg) products are prepared from pooled human plasma from not fewer than 1000 donations and contain mainly immunoglobulin G (IgG) with a broad ...

EMA: Regulatory and procedural guideline: Annex I variation application(s) content for live attenuated influenza vaccines, draft

MAHs shall submit a Type II variation application containing the adequate quality documentation in accordance with Article 18 of Commission Regulation (EC) No 1234/2008, by the Agency recommended ...

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