According to Cabinet Regulation No. of 17 May 2011 .378 “ Procedures for the Advertising of Medicinal Products and Procedures by which a medicinal product manufacturer is entitled to hand over free samples of medicinal products to doctors ” (hereinafter - Regulations), as specified in paragraph 32.2, to registration owners of medicinal products or their authorised representatives, or to other persons who are advertising or advertising distributors, to submit a statement once a year regarding the material or other type provided support for associations, foundations and medical treatment institutions provided in the previous year (hereinafter referred to as “the Notice”).
Turning attention! entered into force on September 07, 2021, Cabinet Regulation No. 602 of 31 August 2021 “Amendments to Cabinet Regulation No. of 17 May 2011”. .378 “Procedures for the advertising of medicinal products and Procedures by which the manufacturer of medicinal products is entitled to transfer free samples of medicinal products to doctors” (hereinafter - Amendments). Paragraph 4 of the amendments provides for changes to the Regulation N of the Cabinet of Ministers of 17 May 2011 R. 378 “procedures for the advertising of medicinal products and procedures by which a medicinal product manufacturer is entitled to transfer free samples of medicinal products to doctors” in paragraph 32.2, providing that, in future, notification regarding the material or other type of aid provided to owners of registration of medicinal products or their authorised representatives, or to other persons who are advertising donors or advertising distributors, notification regarding associations, foundations and pharmaceutical institutions and entities subject to pharmaceutical activities (hereinafter referred to as “the Notice”) must submit to by 30 May. On the other hand, point 6 of the amendments states that the Communication should further specify:
- information on the amount spent on research and development
- information regarding the payment of publications to specialists, specifying the given name, surname, speciality and remuneration of each specialist.
Similar with the amendments adopted, it is specified that Cabinet Regulation No. of 17 May 2011 .378 “procedures for the advertising of medicinal products and procedures by which a medicinal product manufacturer is entitled to transfer free samples of medicinal products to doctors” the requirements shall also apply to pharmaceutical operators (pharmacies, pharmacy branches and drug wholesalers) , who combine pharmacists and pharmacist assistants, which according to Sub-paragraph 2.2 of the Regulations shall be regarded as specialists, who have the right to distribute grass s. And it is also clarified that the Communication contains information on donations and gifts.
- Statements on material or other support provided by associations, foundations and medical treatment institutions in 2020
- Statements on material or other support provided to associations, foundations and medical treatment institutions in 2019
- Statements on material or other support provided to associations, foundations and medical treatment institutions in 2018
- Statements on material or other support provided to associations, foundations and medical treatment institutions in 2017
- Statements on material or other support provided to associations, foundations and medical treatment institutions in 2016
According to the amendments made, the Health Inspectorate has prepared an automated workable form of the Notice containing the data referred to in paragraph 32.2 of Regulation which entered into force on 7 September 2021. For an explanation of the information to be provided in the Notifications columns, see here.
The notification may be submitted by:
- electronically via the State Administration Services portal Latvija.lv, using the e-service "Application for the Health Inspectorate"
- electronically signed document with a secure electronic signature by sending an e-mail address to vi@vi.gov.lv
In case of questions, please contact the Inspection Commercial Practices Department .67081547, email kn@vi.gov.lv