2. European Legislation – Directive 2001/83
1. European Legislation – Directive 2001/83
1.3. Advertising to Prescribers and Suppliers (Healthcare professionals)
Advertising of any medicinal product is allowed to
persons qualified to prescribe or supply products
(1) if essential information compatible with the SmPC is provided and prescription classification (supply classification) is stated.
Member states may also require Information of the price and conditions for reimbursement.
This article concerns any documentation on a medicinal product which is part of the promotion of that product.
1. Documentation shall include, as a minimum, the particulars listed in Article 91(1) and shall state the date of authoring or last revision.
2. All the information shall be accurate, up-to-date, verifiable and complete.
3. Quotations as well as tables and other illustrations taken from medical journals or other scientific works shall be faithfully reproduced and the precise sources indicated.
Interactions between health practitioners and medicinal product providers are governed by Articles 93 to 96.
Medical sales representatives shall be given adequate training and have sufficient scientific knowledge for providing information which is precise and as complete as possible about the medicinal products. This includes the SmPC and, where allowed in a Member State, details of the price and conditions for reimbursement. They shall duly report any information about the use of the medicinal products, particularly any adverse reactions reported to them by the persons they visit.
1) no gifts, pecuniary advantages or benefits in-kind [e.g. services] should be supplied, offered or promised to persons qualified to prescribe and supply medicinal products, unless they are inexpensive and relevant to the practice of medicine or pharmacy’.
2) hospitality at sales promotion meetings should be reasonable and never extended to anyone other than healthcare professionals.
The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals.
The supply of free samples is strictly for health care professionals, only on an exceptional basis, in limited amounts, in response to a written request and identical to the smallest presentation of the product on the market. Each sample shall be marked ‘free medical sample — not for sale’ or shall show some other wording having the same meaning.