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Posts Tagged ‘amendment’

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

New measures to limit the unavailability of medicines – Impact on professional stakeholders

June 7, 2019

Belgium

On 18 May 2019, a new law amending the law of 25 March 1964 on medicines entered into force. This amendment should reduce one of the causes of the temporary unavailability of certain medicines for Belgian patients. It intends to do so by preventing that medicines, supplied in the context of the fulfilment of public service obligations, intended for Belgian patients, are distributed to other countries.

The letter published by FAMHP provides an overview of the practical impact for the stakeholders involved and can be found here.

More information about the amendment of the law can be found here.

New Royal Decree on nutrients

December 5, 2017

The Royal Decree (RD) of 3 March 1992 on food supplements and ordinary foodstuffs enriched with nutrients has been revised and amended.

In this amendment, the list of vitamins, minerals and oligo-elements has been updated, and new maximum levels of these nutrients have been introduced. These are listed in appendix 1 of the RD. Also, the section on mandatory mentions on the packaging has been extended. If particular amounts of certain nutrients are present in the food supplement (e.g. nicotinic acid, or more than 1000 mg of daily potassium), specific warnings have to be added onto the packaging. In addition, percentages of the reference intake of specific vitamins or minerals as determined in the RD, should be mentioned on the packaging as from now.

Amendments included in the new version of the RD have been published in the Belgian Official Gazette on 31 October 2017 and can be found here.