Important legal notice
 
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Summary of Treaty


GENERAL DATA
Official Title Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco
Type of Agreement Bilateral
Date of Signature 04/12/2003
Date of Entry Into Force 01/05/2004
Duration Indefinite
Objective of Agreement To provide legal certainty that the relevant provisions of Community law in the fields of medicinal products, cosmetic products and medical devices are consistently applied and appropriately controlled on the territory of Monaco.
Remarks The Principality of Monaco is not a member of the European Union. EU legislation does not normally apply to Monaco, nor is it consulted on changes to that legislation.

The manufacture and placing on the market of medicinal products, cosmetic products and
medical devices in the EU is regulated by a highly technical set of harmonised Community laws which has, as its main purpose, the protection of public health. The application and administration of these legal instruments is very resource-intensive and requires the existence of highly specialised competent national administrations in Member States. As it is, in practice, neither possible nor proportionate for a very small State like Monaco to create such administrative structures, the task of applying and supervising administrative law in the field of medicinal products, cosmetic products and medical devices in Monaco has traditionally been carried out by - or in close cooperation with - the French competent authorities. There has, however, previously been no clear legal basis to provide legal certainty that the relevant provisions of Community law in the abovementioned fields are consistently applied and appropriately controlled on the territory of Monaco. This legal certainty is needed to provide manufacturers established in Monaco access to the EU market and to give to EU authorities the confirmation that Community law is applied and supervised in a stringent way on the territory of Monaco.

A joint committee will be established, made up of representatives of the parties; it will be responsible for the management and proper application of the agreement
OJ Reference L332, 19/12/2003, p. 42
Nature of Agreement Trade Agreement
Contracting Parties European Community, Monaco
Authentic Texts Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish, Swedish
Subject Matters External Relations
Western Europe
Clause(s)
Territorial application Article 5 Convention
Management Joint Committee (Article 3)
EU PARTICIPATION
Ratification Status NOT
Conclusion Decision Council Decision of 17 November 2003 concerning the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco; OJ L332 of 19/12/2003, p.41
Competence Exclusive
Legal Basis Treaty EC: Article 133



Last Update :   11/08/2009