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Practical recommendations for the new verification system against Falsified Medicines

February 12, 2019

Belgium

In light of the Falsified Medicines Directive, that came into effect on 9th February 2019, FAMHP has issued practical guidelines for the handling of complications during the initial phase of the new verification system.

FAMHP and BeMVO have worked out an “alert”-procedure for when an issue arises during the scanning of a product. These guidelines describe the actions that need to be taken when an alert occurs. It is to be expected that numerous alerts and errors will pop up during the first weeks of operation of  this new verification system without evidence of a falsified product. Therefore, FAMHP has decided to introduce a transition period until 30th April 2019, during which the guidelines of circular letter 644 should be followed.

During this transition period, even though alerts occur during scanning, the pharmacist will still be allowed to deliver the product, provided that several requirements are met. These requirements are described in circular letter 644.

More information can be found here.

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

January 29, 2019

Belgium

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 EMA regulations 2019/5 and 2019/6

January 28, 2019

European Union

On January 7th, 2019 regulation 2019/5 was published in the Official Journal of the European Union “amending Regulation 726/2004, known as the Regulation on the Centralized Procedure. The new Regulation will apply from 28 January 2019.

Regulation 2019/5 combines and integrates the “key elements” of following rules into Regulation 726/004:

–       The rules on conditional marketing authorizations, currently contained in Regulation 507/2006

–       The rules on variations, currently in Regulation 1234/2008 (These rules have also been integrated in Directive 2001/83/EC)

–       The rules on financial penalties that may be imposed on marketing authorization holders of centralized authorizations, who fail to comply with their obligations, currently set out in Regulation 658/2007.

These consolidations are accompanied by several changes within these rules. In several cases, this new Regulation empowers the Commission to adopt new delegated acts that complement the “key elements” now contained in the centralized procedure regulation. In addition to these changes, this new Regulation also describes the financing of EMA.

Regulation 2019/6 removed the rules on veterinary medicinal products from Regulation (EC) No 726/2004 on the centralized procedure and the current Directive 2001/82/EG on veterinary products at national level was repealed.

This new regulation just entered into effect in all member states of the European Union. From now on, all parties involved have three years to ensure compliance with the obligations in this Regulation. The health authorities and all parties involved will make the necessary preparations, at both national and European level to ensure the implementation of this new regulation.

Regulation 2019/6, which will apply as of 28 January 2022, covers all the routes granting marketing authorization for veterinary products in the Union – both at centralized and national level. It should provide more innovation, increase the availability of veterinary medicines by simplifying the regulatory pressure and administrative burden and increase the competition in the veterinary pharmaceutical sector. In addition, a key point of this regulation is to strengthen existing EU laws against antimicrobial resistance. The safeguarding of public health, animal welfare and animal health and the protection of the environment remain the central focus point.

More information can be found here.

 

 

Changes in formulation and content of several codes from ‘The guidelines of the inspection board’ in the Netherlands

January 28, 2019

The Netherlands

After revision of the code for public advertising and medical self-care tools (CPMH), the code for the promotion of health products (CAG) and the code for advertising of medicines (CPG), various adjustments were made:

To make the codes more understandable, multiple changes were implemented to the content and the standards in commandment and prohibition were simplified. Most changes were made to the CAG to align this code with the CPMH and CPG. The most important adaptations were (1) the integration of provisions from the Claims Regulation and (2) the integration of the Database Claims Regulation and the guidance document. In addition, the CAG will most likely become part of the Dutch Advertising Code as of 1 February 2019, just as CPG and CPMH are already part of the Dutch Advertising Code today.

The adjusted codes are available on the inspection board website and have been in effect since the 1st of January 2019.

More information can be found here.

 

New approved disclaimers for health claims for botanicals

January 28, 2019

The Netherlands

The Dutch inspection board published a new list of disclaimers for botanicals that can be used immediately after a health claim. If the disclaimer only applies to a part of the health claim, an asterisk may indicate this. To assure the readability and to prevent confusion, the disclaimer does not have to be mentioned after the shortened health claim on the front of a package.

The list, in use since the 1st of January 2019, includes the following disclaimers:
– Health claim awaiting approval by the European Commission
– Authorization procedure for this health claim is still ongoing
– Evaluation of the health claim is ongoing
– Health claim pending European authorization
– Evidence for this health effect is still being assessed in European authorization procedure
– The health effect has not yet been officially established

Pre-existing approvals for advertisements with botanical claims remain valid until the end of the validity of the approval. Entries without validity period (e.g. packaging), must comply with this the 1st of January 2020 at the latest.

If the advertiser himself can substantiate the claim and does not want to mention a disclaimer, the Inspection Board, together with the Advertising Code Committee, will examine which criteria apply.

More information can be found here.

 

Guidelines on the safe use of essential oils in food supplements

January 8, 2019

France

The French Directorate General for Competition, Consumption and Fraud Prevention (DGCCRF) has published guidelines for the safe use of essential oils in food supplements. These guidelines include a list of plants containing essential oils that can be used for human consumption. Two additional lists of plants are added containing essential oils that are not permitted in food supplements.

The list with permitted essential oils has no legal force. In addition, the list is not exhaustive. Any essential oil derived from plants that is not included in the list yet, can be added through demonstration of their traditional use for human consumption. For this, relevant data should be collected from the literature and sent to the 4A office of the DGCCRF. Of note, if an essential oil is included in the positive list, it is still possible that additional precautions should be taken for its safe use. These recommendations are listed in an additional guidance document provided by the Directorate-General.

More information can be found here.

Happy New Year!

December 21, 2018

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

December 19, 2018

EMA

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

EMA

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

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.