Rules amending the Rules on advertising of medicinal products
R U L E S amending the Rules on advertising of medicinal products
Article 17 of the Rules on advertising of medicinal products (Official Gazette of the Republic of Slovenia no. 105/08) shall be amended to read:
(Advertising in expert publications and with direct informing)
(1) Marketing authorisation holders may advertise the medicinal products which acquired marketing authorisation to expert public in professional books, journals and other professional publications.
(2) Marketing authorisation holders may advertise medicinal products also by direct informing of persons authorised for prescribing and dispensing medicinal products.”
The heading of Article 18 shall be amended to read: “(Data and information on medicinal products)”.
The first paragraph shall be deleted.
In the second paragraph, which becomes the first paragraph, the introductory sentence shall be amended to read:
“(1) Information on medicinal products intended for the expert public, which is designed for persons who are authorised for their prescribing and dispensing, has to include the following data in particular:”.
The previous third to fifth paragraphs shall become the second to fourth paragraphs, respectively.
A new second paragraph shall be added after the first paragraph of Article 19, reading:
“(2) Advertising of medicinal products by means of direct advertising of persons authorised to prescribe and dispense medicinal products and perform the medical activity in the framework of public health service can only be carried out during the time of expert preparation for work not intended for direct work with the patients.”.
The previous second and third paragraphs shall become the third and fourth paragraphs, respectively.
In the first paragraph of Article 22:
- The introductory sentence shall be amended to read:
“(1) Manufacturers of medicinal products and legal entities or natural persons, acting as representatives of manufacturers, may exceptionally submit free samples of prescription-only medicinal products to persons responsible for prescribing medicinal products, when the patient needs to be instructed on the method of use of the new medicinal product, if not intended for oral use and if the following conditions are met:”;
- The third indent shall be amended to read:
“- The person responsible for prescribing medicinal products may only receive one sample of each medicinal product in the smallest packaging for which marketing authorisation has been obtained and for which the marketing authorisation holder informed the body responsible for medicinal products in writing of the actual beginning of marketing pursuant to Article 44 of the Act.”;
- The eighth indent shall be deleted and the previous indents nine to eleven shall become indents eight to ten.
After the third paragraph of Article 23, new fourth and fifth paragraphs shall be added, reading:
“- Keep the list of expert colleagues who advertise medicinal products by means of direct advertising to persons authorised to prescribe and dispense medicinal products, with data on their education;
- The list referred to in the previous indent shall be sent to the body competent for medicinal products with the aim of performing expert supervision in the scope of pharmaceutical control pursuant to the law;”.
The current fifth and sixth indents shall become the indents seven and eight, respectively.
After the second paragraph, a new third paragraph shall be added, reading:
“(3) The responsible person of the marketing authorisation holder must inform the body competent for medicinal products of any change of data from the fifth indent of the previous paragraph within 15 days of their occurrence.”.
After the second paragraph of Article 24, new third and fourth paragraphs shall be added, reading:
“(3) Vaccination medicinal products may only be advertised to the broader public with international non-proprietary names. Advertising must be in line with Article 15 hereof and may not contain elements that would reduce the objectivity of informing on vaccination medicinal products and vaccination.
(4) Advertising of vaccination medicinal products must contain information on all medicinal products with the same indication present on the market of the Republic of Slovenia.”.
A new second paragraph shall be added after the first paragraph of Article 27, reading:
"(2) Based on the data from the list of expert colleagues from the fifth indent of the second paragraph of Article 23 of these Rules, the body competent for medicinal products shall conduct expert supervision in the scope of which it shall check if the conditions for expert colleagues are met, in general, by those working for the marketing authorisation holders.
Marketing authorisation holders shall submit to the body in charge of medicinal products a list of expert colleagues from the fifth indent of the second paragraph of Article 23 of the Rules no later than within one month of the enforcement hereof.
These Rules shall enter into force on the fifteenth day after their publication in the Official Gazette of the Republic of Slovenia.
Ljubljana, 14 December 2010
Dorijan Marušič Minister of Health I hereby agree. Dejan Židan, MSc Minister of Agriculture, Forestry and Food