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Happy New Year!

December 21, 2018

New GVP Product- or Population-Specific Considerations IV published by EMA

December 19, 2018


EMA published the new good pharmacovigilance practice (GVP) Product- or Population-Specific Considerations IV containing specific considerations about pharmacovigilance for the pediatric population. It explains the importance of pediatric pharmacovigilance, the difference with regular pharmacovigilance and provides guidance on how to best use the current tools and processes to obtain an adapted safety monitoring system in children. In addition, it clarifies the roles and competences of the committees concerned and advises on regulatory requirements for the pediatric population in the European Union.


PRAC recommendations on fluoroquinolone and quinolone antibiotics

December 18, 2018


Following a review of disabling and potential long-term side effects of fluoroquinolone and quinolone antibiotics, the Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a restriction of the use of these products. It concerns fluoroquinolone and quinolone antibiotics used by mouth, injection or inhalation. These restrictions include market withdrawal of quinolone containing antibiotics because they are authorised only for infections that should no longer be treated with this class of antibiotics, as well as a change of indication for fluoroquinolone antibiotics and extra safety precautions in certain cases.

More information can be found here.

Updated Annex to the EC guideline on excipients and information in the package leaflet

December 17, 2018


EMA published an updated Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’. The annex contains a list of all excipients known to have a recognised action or effect that need to be displayed on the label of any medicine authorised in the European Union (EU). This annex is reviewed regularly by EMA’s Excipients Drafting Group (ExcpDG) to update the information on excipients or include new excipients. This update reflects a correction of editorial mistakes in the previous version and concerns corrections on the route of administration, the name and the information for the package leaflet for phenylalanine, sodium laurilsulfate and wheat starch, respectively.

The update can be found here.

Safety features for medicinal products for human use – Questions and Answers – Versions 11 & 12

December 12, 2018


Versions 11 & 12 of the Q&A on Safety features for medicinal products for human use have been published in October and November of 2018. Following these updates, multiple questions have been revised (1.20; 1.23; 2.21; 7.15; 8.4; 8.7) and some new questions have been added (5.8; 6.8; 8.8).

Compared to the previous version, the placing of safety features by means of stickers has been defined more in detail. Stickers must be placed under GMP conditions and the outer packaging on which the identifier is placed as a sticker must meet all applicable labelling requirements. Moreover, the use of stickers is not acceptable when the readability of compulsory regulatory information is limited.

More information can be found here.

The Dutch authorities will compensate companies for additional costs due to the Falsified Medicines Directive

December 5, 2018

The Netherlands

As a result of the Falsified Medicines Directive, companies are obliged to adapt the packaging of their medicines which leads to additional costs. These additional costs cannot always be compensated by a price increase, due to the Drug Price Act (Wet geneesmiddelenprijzen). As a pharmaceutical company, it might be challenging to maintain a reasonable profit margin in case of a low sales number and a low pharmacy price.

The Ministry of Health, Welfare and Sport in the Netherlands has therefore decided to compensate these additional costs when the following conditions are met:

  • The medicine concerned has an estimated sales volume of less than 250,000 packages in 2018, and
  • The difference between the maximum price per package and the pharmacy purchase price:
    • at an estimated volume of less than 100,000 packages in 2018: is smaller than €0.34 and €0.34 is 3% or more of the pharmacy purchase price;
    • at an estimated volume of 100,000 to 250,000 packages: is smaller than €0.12 and €0.12 is 3% or more of the pharmacy purchase price; and
  • the pharmacy purchase price is not higher than the maximum price per package.

In summary, this applies to products that are cheaper than €11.33/package (in case of a sales volume of <100,000) or cheaper than €4 (in case of a sales volume of 100,000-250,000).

Applications for compensation of these additional costs need to be submitted before 15 December 2018, 12h:

More information can be found here and in Staatscourant Nr. 60878.

Amendment of the lists on food supplements’ additives

October 26, 2018


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


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


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.