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Amendment of the lists on food supplements’ additives

October 26, 2018

EU

Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council has been revised by the European Commission (COMMISSION REGULATION (EU) 2018/1497). This regulation lists the food additives that are authorized to be used in food supplements and categorizes them according to the food supplements to which they may be added:

  • Subcategory 17.1: Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms
  • Subcategory 17.2: Food supplements supplied in a liquid form
  • Subcategory 17.3: Food supplements supplied in a syrup-type or chewable form

After discussions with Member States, it was found that food subcategory 17.3 often led to misinterpretation. As a result, it was decided that syrup- and chewable-forms should be categorized as liquid and solid forms, respectively.

So, the food subcategories have been renamed as follows:

  • Subcategory 17.1: Food supplements supplied in a solid form, excluding food supplements for infants and young children
  • Subcategory 17.2: Food supplements supplied in a liquid form, excluding food supplements for infants and young children

As a result of the deletion of food subcategory 17.3 food additives’ entries which were included in that food subcategory should be transferred to either food subcategory 17.1 or 17.2 to ensure that there is transparency and legal certainty regarding the use of food additives in those foods.

Furthermore, it was decided to introduction section should be included for each food category clarifying that the maximum (use) level for the food additives refer to the food supplements as ready for consumption.

This amendment will clarify the questions that remained regarding authorized additives for use in food supplements.

Information about the Falsified Medicines Directive

October 26, 2018

The Netherlands

The Falsified Medicines Directive (FMD) (Directive 2011/62/EU) are measures to prevent falsified medicinal products for human use from entering the legal distribution chain.

This includes that all outer packaging of prescription-only medicinal products must bear safety features no later than 9 February 2019. These safety features are: a 2D matrix code and an anti-tampering device (e.g. a seal on the outer packaging) that can verify whether the packaging has already been opened.

Marketing authorisation holders including parallel importers who market prescription-only medicinal products in the Netherlands should contribute to the development and maintenance of the NMVS, a system where the unique identifier information is stored, owned by the Dutch Medicines Verification Organisation (NMVO). After 9 February 2019, no products may be released for the market without the features on the packaging. It is also mandatory to upload product information on the European Hub when the products are released.

The safety features must be applied to packaging of prescription-only medicinal products. However, there are a few exceptions:

  • Certain prescription-only medicinal products (white list): annex 1 of Regulation EU/2016/161.
  • Certain over-the-counter medicinal products (black list): annex 2 of Regulation EU/2016/161.
  • All forms and strengths of radiopharmaceutical products fall beyond the scope of this regulation. Therefore, these products do not have to be provided with safety features.

The European Commission has also published a Q&A on the implementation of delegated regulation 2016/161.

New list of recommended analysis methods for botanicals

October 23, 2018

Belgium

A new list of recommended analysis methods for the use of certain botanicals in food supplements has been published by the Belgian Federal Public Service Health, Food Chain Safety and Environment. A list of 119 plants has been drawn up based on the scientific advice of the Advisory Commission on Botanicals. The methods listed in this document are to be used to check, among others, whether the food supplements comply with the maximum levels or whether the substances are below the threshold values as laid down in the Belgian Royal Decree on Botanicals.

More information can be found here.

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