Aluminates

Scientific advice and orphan drugs

Regulatory affairs and organisational support

Medicinal Products for Human Use

Evaluation of Veterinary

3.3 Other CPMP core activities

INSPECTIONS

NETWORKING

(Human Medicinal Products)

Directive 2000 7 EC of the European Parliament and of the Council of 20 March 2000 on speedometers for two or three wheel motor vehicles

LIST OF PRODUCTS COVERED BY THE ANNEX

CPMP

CVMP

Human Medicines

Human Use

4.2 Implementation of the clinical trials directive

Human Medicinal products

Implementation status

5.5 Information technology

Orphan medicinal products for human use

Herbal medicinal products for human use

Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the requirements for the marketing authorisation of medicinal products (RO 2001 3437), as last amended on 1 January 2013 (RO 2012 5651)

MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION

Chapter 2 Medicines for human use

inspectors by about 25 per annum.

Evaluation of Human Medicines Unit 6

Chapter 2 Medicinal products for human use

Evaluation of Human Medicines Unit

Evaluation of Human Medicines Unit

Evaluation of Medicines for Human Use

Chapter 2 Medicinal products for human use

Peter JONES Head of Unit

Evaluation of Medicinal Products for Human Use

A change from any other heading, except from heading 87.08 or

A change from heading 91.08 through 91.14, whether or not there is also a change from any other heading, provided that the value of non originating materials of heading 91.08 through 91.14 does not exceed 50 per cent of the transaction value or ex works price of the product.

This provision shall apply i.a. to the manufacture of active pharmaceutical ingredients, intermediate products and investigational medicinal products, as well as to pre marketing inspections.

Current version of the Guide to good manufacturing practices contained in volume IV of Rules governing medicinal products in the European Union and compilation of the community procedures on inspections and exchange of information.

With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service.

Systems for medicinal products for human use except that routine updates of the Risk Management ic

Chapter 2 Medicines for Human Use......................................................... .23

Unit for the Evaluation of Medicines for Human Use Operation of the CPMP Other CPMP activities CPMP working parties Ad hoc EMEA working group on herbal medicinal products Mutual recognition of medicinal products for human use

Unit for the Evaluation of Medicines for Human Use

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

Advertising of medicinal products for human use

3.1 Unit for the Evaluation of Medicinal Products for Human Use