NECESSARY AMENDMENTS ON THE DIRECTIVE ON TRADITIONAL HERBAL MEDICINAL PRODUCTS, NEW PROPOSAL AS PART OF DIRECTIVE 2001/83

RAPPORTEUR EP: Mr G. Nisticó

Art.16a

Area of application of the Directive

Unfortunately the Commission has rejected the Parliament’s Amendment 7. The Commission’s proposal however is too narrow and is expected to be interpreted differently in the Member States; the Parliament’s proposal on the other hand is broader and unambiguous. It should therefore be taken up again.

Proposal: The Parliament adheres to its Amendment 7:

(a) they are classified as available without medical prescription;

Art.16.i / Indent 2

Possibility to plan or retain national regulations

for non-herbal traditional medicinal products 

In the Parliament’s justification of Amendment 27 it is rightly explained that without the possibility of special national regulations many traditional medicinal products will have to be taken off the market, against the interest of doctors and patients. This negative development should be avoided.

Proposal: The Parliament adheres to its Amendment 27:

The report shall include an assessment on the possible extension of traditional use registration to other categories of medicinal products. In the absence of such an extension, a Member State may introduce or retain in its territory specific regulations for traditionally used non-conventional medicinal products other than those referred to in Article 16 a. The regulations on quality and safety and efficacy should be in accordance with the respective principles and characteristics of the non-conventional therapeutic approaches.

In this case, the Member State concerned shall notify the Commission of the specific rules in force.