15 Feb News from Belgium: serialization transitional period
On February 9, 2019, the European Falsified Medicines Directive (Directive 2011/62/EU) came into effect. The Belgian Federal Agency for Medicines and Health Products (FAMHP) has bundled some practical guidelines for dealing with problems in the start-up phase into a circular letter and has decided to set a transitional period.
From 9 February 2019, most prescription and reimbursable medicines placed on the market must bear safety features. At each link in the distribution chain, the safety features are checked so that the authenticity of the medicine can be guaranteed upon delivery. Although the roll-out in Belgium is relatively smooth, due to the high complexity, the verification system will probably have a number of growing pains, both in terms of information technology developments and changes in the production and distribution chain.
The Belgian Medicines Verification Organization (BeMVO) has, in consultation with the FAMHP, developed an “alert” procedure for “alerts” or error messages when scanning a product. This procedure, the first of its kind in the entire European Union, must be followed in case of error messages when scanning products. The experience in the development and testing of the system has shown that, especially in the first weeks after the system becomes operational, a lot of error messages can still be expected where it is not related to counterfeit. For example, there will still be products with a unique code, which were put on the market before 9 February 2019, but which will not be in the system. It may also concern products where the code applied is incorrect or possibly other errors in the developed software. Due to these errors, it is possible that products are not recognized by the database, but the FAMHP believes that this cannot be regarded as a “suspicion that the product is not compliant”.
The FAMHP has therefore decided that, until 30 April 2019, the legislation should be interpreted as set out in circular letter 644. During this transition period, the focus remains on ensuring the availability of medicines for the patient without eroding the new protection afforded by the Directive.
Specific recommendations for pharmacists, marketing authorization holders, manufacturers of a manufacturing or distribution license are set out in circular letter 644 (French and Dutch version only).
Consultant: www.farmaconsult.be