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Posts Tagged ‘royal decree’

New Royal Decree with regards to the implementation of the Falsified Medicines Directive

May 9, 2019


On February 8, 2019, the Belgian Official Gazette published a Royal Decree amending both the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 concerning instructions for pharmacists.

The modifications that have been made with regards to the implementation of the Falsified Medicines Directive, include: “Without prejudice to Article 6septies, § 2 of the Act, the unique identification mark is included on the packaging of all reimbursable, non-prescription medicines whose reimbursement is not limited to delivery at the hospital.”

More information can be found here.

Liberalization of the Belgian Distribution Channel for Medical Devices: a New Royal Decree

January 29, 2019


On 28 January 2019, the new Royal Decree of 19 DECEMBER 2018 on the liberalization of the distribution channel for medical devices has been published in the Belgian Official Gazette. The new Royal Decree will come into force on 7 February 2019.

The most important changes imply that, as of 7 February 2019, the Belgian distribution channel for Medical Devices and Active Implantable Medical Devices is no longer restricted to (hospital) pharmacies. From that date, patients and healthcare professionals can purchase medical devices, such as sterile bandages or physiological serum, directly from any distributor, from pharmacy to supermarket, and even directly from the manufacturer. The distribution of medical devices will also be facilitated for laboratories, nursing homes and private clinics.  This liberalization should ensure that the access of end-users and patients to medical devices is better aligned with the principles of free movement of products with CE Marking within Europe. Nevertheless, the liberalization shall have no impact on the safety or efficacy of the medical devices on the Belgian market and does not affect the reimbursement conditions set by the RIZIV/INAMI.

In Belgium, all distributors and exporters must be registered with the FAMHP. For manufacturers, there is currently no direct obligation to register.

More information can be found here.


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.

Autocontrol and ‘only once-principle’

February 6, 2018


The Royal Decree of 15 November 2017 regarding the notification of a materiovigilance contact point and the registration of distributors and manufacturers of medical devices concerns the introduction of a new registration procedure that should limit the administrative burden following the ‘only once-principle’. So, the aim is to collect all information that is already known within the authorities (KBO/BCE, VAT databank).

Practical consequences?

  • ABGD/SADN application will be replaced by a new web portal
  • Manufacturers and importers will no longer be encoded by the system as ‘distributor’ but instead according to their exact activity

Additionally, new rules are laid down in this Royal Decree concerning market surveillance of medical devices.

New Royal Decree on nutrients

December 5, 2017

The Royal Decree (RD) of 3 March 1992 on food supplements and ordinary foodstuffs enriched with nutrients has been revised and amended.

In this amendment, the list of vitamins, minerals and oligo-elements has been updated, and new maximum levels of these nutrients have been introduced. These are listed in appendix 1 of the RD. Also, the section on mandatory mentions on the packaging has been extended. If particular amounts of certain nutrients are present in the food supplement (e.g. nicotinic acid, or more than 1000 mg of daily potassium), specific warnings have to be added onto the packaging. In addition, percentages of the reference intake of specific vitamins or minerals as determined in the RD, should be mentioned on the packaging as from now.

Amendments included in the new version of the RD have been published in the Belgian Official Gazette on 31 October 2017 and can be found here.

When does the Sunshine Act come into force?

April 14, 2017


On December 27th 2016, the Sunshine Act was adopted in Belgium. It introduces a new transparency obligation applicable to the pharmaceutical and medical devices industries. The legislation requires pharmaceutical manufacturers, importers and distributors, as well as retailers and medical device manufacturers, to disclose all pecuniary advantages or benefits provided to healthcare professionals, healthcare organisations and patient associations registered in Belgium. According to this law, any transfer of value in money or in kind must be notified to the FAMHP.

For this law to be effective, two Royal Decrees on the disclosure obligation are in preparation. The first Decree concerns the types of transfers of value and the practical and technical arrangements. In the second Decree, an organization -anticipated to be Mdeon- will be assigned responsibility to perform the functions and tasks on behalf of the FAMHP. After publication of these Decrees, the Sunshine Act can enter into force. This is expected for April 2017.

The obligation to disclose will however apply to all transfers of value provided from January 1st 2017 to December 31st 2017. Related notification of these transfers of value is due likely by May 31st 2018 at the latest. A record of all transfers of value must be kept by companies for a period of 10 years from the date of publication.

New Royal Decree on herbals

March 21, 2017

On January 24th 2017, the new Royal Decree on the manufacture and distribution of food supplements containing herbs or herbal preparations was published, adapting the RD of August 29th 1997. The main change concerns the addition of many botanicals from the BELFRIT list: the harmonized list of admissible plants in food supplements, as jointly defined by BELgium, FRance and ITaly.

In the new Royal Decree, the number of authorized plants has been increased from 645 to over 1.000. Additionally, maximum levels and mandatory warnings have been added for several herbals. This should help encouraging and facilitating the free movement of supplements based on herbal ingredients in the EU, also ensuring at the same time a higher level of protection for consumer safety.

The Royal Decree factored in a transition period, allowing food supplements that do not comply to sell through up to two years after the decree came into force.