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The Mdeon Code of Ethics has been updated

October 19, 2018

Belgium

The main reason for the update of the Mdeon Code of Ethics is to align it with the Sunshine Act. Simultaneously, the Practical Guidelines of the code have been adapted as well.

The two major changes are:

  1. Adaptation of the chapter on the transparency obligation according to the Sunshine Act (Chapter 1 of Title 3 of the Law of 18 December 2016 on various health provisions).
  2. Adaptation of the Practical Guidelines related to Article 3 of the Code of Ethics according to the caselaw applied by the Visa Office for 10 years, in particular the fact that the sponsorship of scientific training courses should always aim at continued medical education of the healthcare professionals. This means that it should therefore always be possible to combine the training course with the exercise of their profession without interrupting it for a long time. Long-term scientific training courses (i.e. more than three weeks) can therefore not be sponsored by the industry (e.g. fellowship of several months, additional year of study) since these are no scientific events within the meaning of article 10 §2 of the Law concerning medicines.

The 2018 version of the Code of Ethics and Practical Guidelines can be found on the Mdeon website.

New EU GMP directive

October 18, 2018

Belgium

The European Union (EU) has published its new directive for manufacturers of pharmaceutical products. This directive replaces the existing directive (Directive 2003/94/EC) on medicinal products for human use. The new EU Good Manufacturing Practice (GMP) directive, Commission Directive (EU) 2017/1572, came into effect on 31 March 2018. The new EU GMP Directive removes all aspects of the manufacturing of medicines for research which will make the Directive on finished products easier to read. The manufacturing of medicines for research will become subject to separate legislation, namely Regulation 2017/1569. The new EU GMP Directive has a similar structure as the existing one and many of the requirements remain the same.

This new EU GMP Directive was transposed into Belgian law via the Royal Decree of 27 June 2018, amending the RD of 14 December 2006.

Envelope with white or red hand for important risk-communication

October 16, 2018

The Netherlands

As from 11 June 2018, all healthcare professionals will receive Direct Healthcare Professional Communications (DHCPs) and additional risk-minimization materials in an envelope marked with a white or orange hand.

These measures were taken by the medicines evaluation board (MEB) to increase the recognizability of this important information.

The ‘orange hand envelope’ already exists and remains in use. It will be used for particularly important or urgent DHPCs. The ‘white hand envelope’ is new and will be used to communicate all additional risk-minimization material.

More information can be found here.

New Advisory Group for borderline medicinal products

October 15, 2018

The Netherlands

An ‘Advisory Group on the Status Determination of Medicinal Products has been established in the Netherlands. This Advisory Group is composed of expert representatives from IGJ, NVWA, MEB and CCMO. The ‘Advisory Group’ advises on which legislation applies to individual products, product groups or substances at the time of assessment and given the available information, including factual information but also applicable case law and information from other countries. The advice is recorded in a database managed by the secretariat of the ‘Advisory Group’ and publicly available.  For the time being, healthcare companies remain dependent on private advice regarding market access of their products as only the listed authorities can request advice from the Advisory Group and not individual healthcare companies.

More information can be found here.

To be compliant with the new GDPR…

May 25, 2018

You have provided some contact details (including but not limited to name, first name and e-mail address, hereafter your “personal data”) to IN2Pharma NV, whose registered office is located at Terloonststraat 22, 1910 Kampenhout, Belgium.

IN2Pharma hereby informs you that it shall solely process your personal data for customer/supplier management and informing you on our events or regulatory updates in pharma & healthcare. By providing IN2Pharma with your personal data, you acknowledge that the processing of your personal data is necessary to meet this purpose. IN2Pharma shall only communicate such personal data to its personnel and contractors to the extent necessary for the above purpose.

Your personal data may be stored by IN2Pharma as long as necessary to satisfy legal requirements and to achieve the above purpose or for a shorter period if you inform IN2Pharma that you do no longer wish to be listed in its database.

Your personal data shall not be transferred to a country outside of the EEA.

You have the right to (i) access your personal data; (ii) request the correction of your personal data if and to the extent you can prove such data is inaccurate; (iii) request the deletion of your personal data if the conditions of the General Data Protection Regulation are met; (iv) limit the processing of your personal data based on Article 6.1 (f), (v) object to the processing of your personal data on grounds relating to your personal situation and/or request its restriction; and (vi) request a copy of your personal data in a structured, commonly used and readable format.

You can exercise these rights any time by writing to IN2Pharma at privacy@in2pharma.com. If you only want to unsubscribe from the newsletter with regulatory updates in pharma & healthcare, you can do so by clicking this link: http://in2pharma.com/unsubscribe.

Updated Blue Box requirements

May 24, 2018

Belgium

The CMDh has updated the Blue Box requirements on 2 March 2018. Henceforth, mentioning the reimbursement category on the labeling of medicinal products is no longer required in Belgium.

Marketing authorization holders are required to remove the reimbursement category of existing products within 5 years.

The revised Blue Box requirements 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.

Prohibition of medical claims for health products also applies to (specific combinations of) ingredients

May 23, 2018

The Netherlands

It is forbidden to make medical claims for healthcare products that are not registered as medicines such as food supplements. Only claims that are approved by European Food Safety Authority (EFSA), including ‘on hold’ claims for botanicals, can be used.

The prohibition of medical claims for health products also applies if medical claims are made on the website of a foundation for specific ingredients or a specific combination thereof. The Dutch Advertising Code Committee (Reclame Code Commissie, RCC) believes that descriptions of the combinations that exactly match certain products and claims that contain direct and indirect references to those products fall under inadmissible advertising. As a consequence, the RCC judges that such discussions of the individual ingredients are not neutral and not purely informative.

Therefore, the RCC has decided that also the sponsor of a website can be held responsible for the claims on the website. The RCC judges that the (content of) claims by third parties on a website, such as testimonials from physicians and reactions of consumers, fall under the responsibility of both the foundation and the sponsor.

This independent judgment of the RCC provides more clarity about the way in which advertising rules must be interpreted and applied, which is in the interest of public health and combats unfair competition.

More information can be found here.

New template for RMS

May 22, 2018

EU

Due to Brexit, there is a higher number of files for changes in Reference Member State (RMS). That is why CMDh (Coordination Group for Mutual Recognition and Decentralized Procedures, Human) developed a new template allowing this to run more efficiently. This template should be used for all RMS change requests from now on. The template contains all required information so that no additional information is required afterwards.

In parallel, CMDh also adapted the file CMDh procedural advice on changing the RMS, which explains the use of the template and provices additional information on the procedure.

Source: Website FAMHP