Phytopharmaceutical products

Projet de Loi No. 34-18 Relative aux produits phytopharmaceutiques (Draft Law No. 34-18 on phytopharmaceutical products

The draft law in question provides mainly for the following:

-         The evaluation of phytopharmaceutical products in two different stages:

·           The first stage entails the evaluation and approval of active substances, safeners and synergists that may form part of the composition of phytopharmaceutical products;

·           The second entails evaluating and authorizing the placing on the market of commercial preparations containing previously approved active substances, safeners and synergists.

-         The placing on the market of products that pose a negligible risk to human or animal health or to the environment:

·           by introducing requirements that are less stringent than for other products;

·           by extending the period of validity for the approval and authorization of the placing on the market of the product to 15 years (as opposed to ten years for other products).

-         The re-evaluation, at any time, of products placed on the market, where information comes to light showing that the requirements on the basis of which the products were authorized are no longer being met, particularly as regards the products' effects on human and animal health and the environment;

-         The requirement that holders of phytopharmaceutical products notify any potentially harmful effects their products may have as soon as they become aware of them, and that the competent authority ensure the list of authorized products is made publicly available; The establishment of requirements for conducting activities involving the import, repackaging, distribution and use of phytopharmaceutical products. These most notably include the requirement to provide proof of access to premises that meet the safety and hygiene standards set out in existing regulations, and the requirement to show that employees hold individual certificates issued upon the completion of a training course relevant to the activity they are required to carry out or on the basis of a diploma that they already hold;

-         The increased monitoring of trade in phytopharmaceutical products, so as to ensure compliance with the provisions of the law and the traceability of these products from the time they are imported or manufactured through to when they are used; The inclusion of the settlement procedure, which will be applicable only for offences punishable by fine.