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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

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.

Policy Rules on Inducement

February 27, 2018

The Netherlands

The Policy Rules on Inducement in the Medicines Act have been adapted and will go into effect on 1 April 2018. The main reasons for the adaptations were 1) unclarity on the limits of hourly rates for services to medical specialists, and 2) differences in some topics as compared to the Policy Rules Inducement Medical Devices Act which has become effective on 1 January 2018.

Among others, the definitions of healthcare professional and entrepreneur, the conditions for sponsoring, the maximum value of gifts and hospitality if provided through a third party have been supplemented and/or adapted.

More details can be found here.

Finally, clear provisions on the fiscal importation of medicines from third countries

February 12, 2018

FAMHP

It is not allowed for Wholesaler’s Distribution Authorization (WDA) holders to purchase medicines from companies based outside the European Economic Area (EEA) if these medicines were manufactured within the EEA and released by the qualified person of the batch releaser in the EEA, so when the medicines did not leave the EEA physically nor underwent any manufacturing operation in the period between batch release and the purchase from the company located outside the EEA.

A wholesaler may only purchase medicines from other authorized wholesalers within the European Union (EU).If a wholesaler wants to purchase medicinal products  from manufacturers or wholesalers outside of the EU, an import license is required according to art. 12 bis of the medicines law of 25 March 1964.

This clear communication will end constructions with invoices passing by Switzerland for fiscal optimization.

More information can be here.

Adapted guidelines on labeling and packaging of human medicines

February 12, 2018

FAMHP

The guidelines on labeling of medicines have been adapted. With these adaptations, the guidelines are more in line with the European and other national and international guidelines.

Main changes are:

  • Information in braille: the strength and/or pharmaceutical form only have to be added on the packaging of medicines if different strengths and/or pharmaceutical forms of this medicine exist. In case the strength is in micrograms, it is sufficient to mention ‘mcg’ in braille.
  • Unique identifiers (2D matrix code and human readable information) have to be added according to the QRD-template.
  • The definition of small packages has been expanded.
  • The definition and submission of mock-ups have been added.
  • Information on the use of trade marks, symbols ® and TM, or ‘brand of’: these marks are not accepted due to their promotional nature and as they are not useful for the patient. However, there have been some exceptions.
  • Information on the use of logos and QR codes.
  • Additional section on the labeling of combination packages and labeling of homeopathic medicines.

The complete guideline on labeling of medicines can be consulted here.