The rules governing medicinal products in the European Union - Regulatory Issues

The rules governing medicinal products in the European Union
Volume 5
Pharmaceutical legislation
THE RULES GOVERNING MEDICINAL PRODUCTS IN
THE EUROPEAN UNION
Volume 1 Pharmaceutical legislation
Medicinal products for human use
Volume 2 Notice to applicants
Medicinal products for human use
Volume 3 Guidelines
Medicinal products for human use
Volume 4 Good manufacturing practices
Medicinal products for human and veterinary use
Volume 5 Pharmaceutical legislation
Veterinary medicinal products
Volume 6 Notice to applicants
Veterinary medicinal products
Volume 7 Guidelines
Veterinary medicinal products
Volume 8 Maximum residue limits
Veterinary medicinal products
Volume 9 Pharmacovigilance
Medicinal products for human and veterinary use
FOREWORD
Since the adoption of the first pharmaceutical directive in 1965, the pharmaceutical legislation of the European Union has constantly pursued two objectives: the protection of public health and the free movement of products.
The criteria and procedures for the approval of human and veterinary medicines, as well as several other important aspects of pharmaceutical legislation, have been extensively harmonised within the European Union. European pharmaceutical legislation now covers all industrially manufactured medicines, including vaccines, blood derivatives, radiopharmaceuticals and homeopathic medicines.
The provisions applicable to medicinal products in the European Union include:
? a binding legislation (regulations and directives);
? a notice to applicants for marketing authorization describing the administrative procedures to be followed and the format of the application file;
? guidelines ono the conduct of the quality, safety and efficacy studies which must be carried out in support of an application for marketing authorization;
? a detailed guide to good manufacturing practice;
? a detailed guide to drug monitoring.
These texts are brought together in a series of volumes entitled ?The Rules governing medicinal products in the European Union?, published by the Office for Official Publications of the European Communities and listed on the preceding page.
The present volume is the fifth of the series and consists of all the legislation applicable to veterinary medicinal products. This legislation is divided into two principal categories: directives,
which need to be transposed into national law by the Memmber States, and regulations, which are directly applicable in the internal legal order of each Member State. The third part contains
texts which, while not, strictly speaking, forming part of the pharmaceutical legislation as such,
are nevertheless closely linked to it.