Article 11

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1989 at the latest. They shall forthwith inform the Commission thereof.

Before the date referred to in paragraph 1, Member States shall communicate to the Commission the texts of any laws, regulations or administrative provisions relating to the pricing of medicinal products, the profitability of manufacturers of medicinal products and the coverage of medicinal products by the national health insurance system. Amendments and modifications to these laws, regulations or administrative provisions shall be communicated to the Commission forthwith.