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Posts Tagged ‘FAMHP’

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

Invoices replace advance payments

June 7, 2019

Belgium

The FAMHP has published a news item on their website concerning payments to the FAMHP. From now on, the FAMHP will send out invoices with structured message for most of its services. As a result, companies will no longer need to make advance payments (via an exact advance payment or via an allowance account) when submitting files in Belgium.

More information about the transition period:

  • During the current transition period, companies can receive an invoice for a contribution that they have already (partially) paid via an advance payment.  If that is the case, the FAMHP asks them to communicate the invoice number and proof of their advance payment in an e-mail to fin@famhp.be
  • Companies currently working with an allowance account should send an e-mail to fin@famhp.be  The FAMHP will refund allowances upon simple request. The FAMHP will no longer use the credit in allowance accounts to pay fees. All companies will now pay their fees after receiving an invoice with a structured message.

More information can be found here.

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.

Encoding errors in the Article 57 database of EMA

April 9, 2019

Belgium

The FAMHP  Vigilance department has found several encoding errors in the Article 57 database of the EMA. Some medicines licensed in Belgium appear two or three times in the database, in two or three national languages. As a result, they are registered multiple times for the same marketing authorization (MA). Every medicine may only be coded once based on the MA number (BE #).

As MA holders are encouraged by EMA to carefully check and correct the registered entries of their different medicines in the database if necessary, FAMHP is asking marketing authorization holders to check whether their registered data are correct.

 

More information can be found here.

Practical recommendations for the new verification system against Falsified Medicines

February 12, 2019

Belgium

In light of the Falsified Medicines Directive, that came into effect on 9th February 2019, FAMHP has issued practical guidelines for the handling of complications during the initial phase of the new verification system.

FAMHP and BeMVO have worked out an “alert”-procedure for when an issue arises during the scanning of a product. These guidelines describe the actions that need to be taken when an alert occurs. It is to be expected that numerous alerts and errors will pop up during the first weeks of operation of  this new verification system without evidence of a falsified product. Therefore, FAMHP has decided to introduce a transition period until 30th April 2019, during which the guidelines of circular letter 644 should be followed.

During this transition period, even though alerts occur during scanning, the pharmacist will still be allowed to deliver the product, provided that several requirements are met. These requirements are described in circular letter 644.

More information can be found here.

 

New financing law FAMHP 26/03/2018

May 24, 2018

FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) published a new financing law in the Official Gazette (Staatsblad/Moniteur Belge).  This new financing law is effective as from 5 April 2018.

The intention of this new financing law is to better align the costs associated with FAMHP services with their funding and to avoid unnecessary costs, without a negative effect on the quality of the protection of public health.

The impact in a nutshell:

  • An increase of the contributions for the pharmaceutical industry.
  • A general tendency of decrease of the fees.
  • A general tendency of increase of the collective contributions.

This new law might have a considerable impact on budget planning.

All information on this new financing law can be found on the website of the FAMHP. However, most information is only available in Dutch and French:

In Dutch
In French
In English

Adaptation of RMA approval procedure

May 23, 2018

FAMHP

Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted.

This article was amended to adapt the deadlines for the evaluation and approval of RMAs. Henceforth, submitting or not submitting the dossier to the Committee for medicines for human use for an opinion will no longer have an impact on the dossier evaluation deadline.

Furthermore, each application is now subject to the payment of a fee. Two different amounts are stipulated depending on the type of dossier. These amounts can be consulted on the website of the FAMHP under fees.

The new procedure is detailed in circular 635 on the RMA approval procedure by the national competent authorities. This new circular replaces circular 603, dated 23 September 2013, which no longer applies.

The form (see Dutch and French) to be filled in for submission of a RMA approval application has also been adapted.

Simplified procedures for homeopathic and (traditional) herbal medicines

May 22, 2018

Belgium

As from 1 May 2018, the FAMHP has simplified a number of procedures for homeopathic and (traditional) herbal medicines. These modifications should streamline the process and reduce the administrative burden for companies and the health authorities.

Following simplifications have been applied:

  • The marketing authorization (MA) or registration of a homeopathic or (traditional) herbal medicine is innovated. The introduction of a so-called “MA light” instead of an MA for herbal or homeopathic remedies.
  • Guidelines for the submission of a file for a homeopathic or a (traditional) herbal medicine are provided.

More information can be found here.

Call for verification of delivery status

January 24, 2018

FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) calls on Marketing Authorization Holders (MAHs) to verify the delivery status of their medicinal products.

Prescription medicinal products are classified into following categories:

  • medicinal products on medical prescription for non-renewable delivery;
  • medicinal products on medical prescription for renewable delivery (oral contraceptives);
  • medicinal products subject to special medical prescription (psychotropic substances and narcotics);
  • medicinal products subject to “restricted” medical prescription, for example, those reserved for treatments that may only be followed in hospital environments or due to the fact that the diagnosis of the disease for which they are being used must be made in a hospital environment or because a prescription drawn up by a specialist is required.

The “restricted” medical prescription medicines are further classified into subcategories as established by the concerned industry, pharmacist associations, hospital pharmacists, nursing staff representatives, the INAMI-RIZIV, academics, and patients’ representatives. These subcategories are as follows:

  • medicinal products intended for individual medication preparation (IMP);
  • medicinal products for which delivery is reserved for hospital pharmacists;
  • medicinal products for which the first medical prescription must be made by a medical specialist and for which delivery may occur in a retail pharmacy;
  • medicinal products for which the prescription and/or administration are reserved for medical specialists and for which delivery may occur in a retail pharmacy;
  • medicinal products subject to specific legislation.

FAMHP now provides the opportunity for MAHs to verify and, if necessary, comment on the legal status of their medicines prior to publication.

More information can be found on the FAMHP website.

Falsified Medicines Directive: joint declaration

September 27, 2017

Belgium

Riziv/Inami, FAMHP and BeMVO published together a joint declaration concerning the implementation of the Falsified Medicines Directive (FMD) in Belgium. In this joint declaration, several arrangements have been laid down to optimize the cooperation between the above-mentioned health authorities in accordance with the FMD. Among others, the starting date, the FMD score for Belgium, the alignment with Grand Duchy Luxembourg, instructions for package design and submission of variations, and major milestones of the implementation have been included.