We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy. Learn more here.Close Me
In Belgium, businesses require an authorization to manufacture, import and/or distribute pharmaceuticals in the Belgian territory. In addition to this marketing authorization, each medicinal product intended to be marketed in Belgium must be properly registered. Both the marketing authorization and the registration are delivered by the Ministry of Public Health. The applicant must comply respectively with the procedures described in the Royal Decrees of June 6, 1960 and July 3, 1969, as modified. These procedures have been implemented in accordance with EU Directives.
Recently, in addition to the local registration systems of medicinal products in each EU Member State, the EU Council has enacted a Regulation organizing a centralized registration system at the European level.
This Regulation (Council Regulation 2309/93 of July 22, 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products) entered into effect on January 1, 1995 and is directly applicable in the Member States. The European Medicinal Evaluation Agency (EMEA) is based in the U.K., London E14 4HB, Westferry Circus 7, Canary Wharf. Its activities have effectively started on January 26, 1995.
The new centralized system is applicable to all medicinal products listed in the Annex attached to the Council Regulation (such as products developed by means of certain biotechnological processes). The system is compulsory for the medicinal products listed in Part A of this Annex. It may be freely selected for the products listed in Part B of this Annex, in lieu of the existing decentralized systems of the Member States.
The decentralized systems remain applicable for all medicinal products not listed in the above Annex as well as, at the applicant's option, for the products listed in Part B of this Annex.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
For further information contact Tanguy Van Overstraeten on +32.2.517.94.05.
The Finnish Supreme Court has ruled on environmental liability in four different cases after the Act on Compensation for Environmental Damage came into effect in 1995.
January 2013 saw the long-awaited ruling of the Dutch court in the five cases brought by campaigning NGO Friends of the Earth against Royal Dutch Shell.
Large scale infrastructure projects in the UK and around the world are under increasingly close scrutiny from campaigning NGOs and ethical investment indices.
Mozambique is one of the largest power producers in Southern Africa. The Cahora Bassa dam, built some 30 years ago in the Tete province, is Africa's second largest hydroelectric plant and supplies South Africa with what is considered to be the cheapest electricity in the world.
Over recent years, the waste and recycling industry has developed the unenviable reputation as being one of the most dangerous sectors for both employees and members of the public.
The ICC Uniforms Custom and Practice for Documentary Credits (currently UCP 600) is a set of contractual rules frequently included by express agreement into a documentary credit transaction.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
