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Posts Tagged ‘registration’

New Company Code requires marketing authorisation holders to amend their documents

July 30, 2019

Belgium

The new Belgian Company Code, which concerns companies and associations, and which came into force on 1 May 2019, refers to only 4  corporate forms. This will have implications for some authorisations and registrations in the sense that holders thereof are now required to amend their documents.

The private limited liability company (besloten vennootschap met beperkte aansprakelijkheid – bvba or société privée à responsabilité limitée – SPRL) and cooperative limited liability company (coöperatieve vennootschap met beperkte aansprakelijkheid – cvba or société cooperative à responsabilité limitée – SCRL) are among the corporate forms that have been abolished, having now been restyled as private company (besloten vennootschap – bv or société à responsabilité limitée – SRL) and cooperative company (coöperatieve vennootschap – cv or société coopérative – SC), respectively. The holder of a marketing authorisation (MA) for a medicinal product is stated inter alia in the medicine’s product information. This means that MA holders are now required to amend their documents. The holders of other authorisations and registrations are required to do the same.

How to amend documents relating to other authorisations or registrations with FAMHP
The new Company Code does not affect the validity of other authorisations or registrations, such as activity licences, import and export licences, or registrations as an economic operator. To communicate the new form of your company to us, please inform us when your authorisation comes up for periodic renewal:

  • Your correct corporate form must be stated on your authorisation by 1 January 2024 at the latest. That is also the last date upon which you may submit any amendments to your articles of association.
  • If you need an amended authorisation, i.e. one that states your correct articles of associations, please request one by writing to the ordinary contact address for your type of authorisation.
  • The validity period of your authorisation will remain the same. It will not be extended as in the case of a renewal.

Source: https://www.famhp.be/en/news/new_company_code_requires_marketing_authorisation_holders_to_amend_their_documents

Autocontrol and ‘only once-principle’

February 6, 2018

Belgium

The Royal Decree of 15 November 2017 regarding the notification of a materiovigilance contact point and the registration of distributors and manufacturers of medical devices concerns the introduction of a new registration procedure that should limit the administrative burden following the ‘only once-principle’. So, the aim is to collect all information that is already known within the authorities (KBO/BCE, VAT databank).

Practical consequences?

  • ABGD/SADN application will be replaced by a new web portal
  • Manufacturers and importers will no longer be encoded by the system as ‘distributor’ but instead according to their exact activity

Additionally, new rules are laid down in this Royal Decree concerning market surveillance of medical devices.