Masterarbeit

Article 35 referral procedures of Directive 2001/82/EC - Evaluation of Article 35 referral procedures in the years 2001 – 2014 ***

Saskia Reßmeyer (2015)

Summary
Language: English
The European pharmaceutical legislation on veterinary medicines lays down in Directive 2001/82/EC as amended, different procedures to resolve issues which may arise about the safety or risk-benefit ratio of a medicine or a class of medicines and to resolve disagreements about assessment of variations. This thesis focuses on Article 35 referral procedures, which are initiated in case the „Community interest“ is concerned, which is the case if the idea of a single market is affected or if there is a potential risk to human or animal health or to the environment. This kind of referral procedure therefore mainly is initiated in case of concerns related to the composition, indication, dosage and administration route or withdrawal period. Article 36-38 of Directive 2001/82 EC lay down the procedure to be followed.
Within the years 2001-2014 24 referral procedures under Article 35 of Directive 2001/82 EC were started and 23 finalized (2 of them in 2015). The procedure length varied all over the years and was independent from the number of products concerned, the Concerned Member States, the initiator and/or the issue of the procedure.
10 Article 35 referral procedures were initiated due to concerns of a potential serious risk to human health. 3 referral procedures under Article 35 of Directive 2001/82/EC were initiated because of a potential serious risk to animal health. Further 8 procedures were initiated due to concerns of a potential serious risk to human and animal health. In two cases concerns about a potential serious risk to the environment were the reason for initiation. One further procedure was initiated due to a potential serious risk to the environment and to human health. 16 of the 24 referral procedures concerned veterinary medicinal product containing an active substance which belongs to the group of antibiotics and further 3 referral procedures concerned antiparasitic veterinary medicinal products. Subject of the remaining 5 procedures were products belonging to the class of Non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, hormones, micronutrients and anthelmintics.
In the new proposed legislation the former Article 35 referral procedure is now included in Chapter IV, Section 8 „Union interest referral“.
The procedure seem to be and remain to be a potent legislative tool to prevent potential serious risks which may arise from a medicinal product/class of medicinal products.
Pages: 73, Annexes: 3, Pages: 76