The requirements for the gift of medicinal products are laid down in Regulation No 416 of 26 June 2007, Procedures Regarding the Distribution and Quality Control of Medicinal Products (hereinafter – Regulation No 416).
In accordance with Sub-paragraph 5.8 of Regulation No 416, a gift of medicinal products is the distribution of medicinal products free of charge in conformity with the requirements laid down in Paragraph 10 of this Regulation, regardless of which market participant donates the medicinal products.
Medicinal products shall be gifted only to a medical treatment institution or social care institution in conformity with the requirements of the laws and regulations regarding the procedures for the acquisition, storage, use and registration of medicinal products in medical treatment institutions and social care institutions.
Medicinal products can be gifted only after a written consent of a medical treatment institution or social care institution has been received for the receipt of specific medicinal products, in which the international non-proprietary name, strength or concentration, form, quantity in one package and number of packages of the medicinal products to be gifted are indicated. If medicinal products are gifted to a medical treatment institution, the gifted medicinal products and the quantity thereof shall conform to the activity profile and scope of work of the medical treatment institution and shall be suitable for the treatment of patients present in the medical treatment institution. If medicinal products are gifted to a social care institution, the gifted medicinal products shall be suitable for the treatment of patients present in the social care institution.
Important! Only registered over-the-counter medicines can be gifted to social care institutions.
The medical institution is allowed to receive as a gift:
- registered medicinal products which are not included on the schedule of reimbursable medicinal products (does not apply to medicinal products of Schedule C and cases when the medicinal products of the schedule of reimbursable medicinal products are intended for a patient with such a diagnosis at which the purchase of such medicinal products is not reimbursed (information regarding the current schedules of reimbursable medicinal products and the list of diagnoses and international non-proprietary names are available on the website of the National Health Service, in the section "Schedules of reimbursable medicinal products"));
- unregistered medicinal products available for compassionate use (in accordance with Article 83(2) of Regulation (EC) No 726/2004 of the European Parliament and of the Council within the scope of the program referred to in Sub-paragraph 3.3 of Article 943 of Regulation No 416) only if the medical treatment institution is indicated in the relevant authorization for the distribution of unregistered medicinal products. The person gifting medicinal products shall ensure the fulfillment of the conditions of Article 83(8) of Regulation (EC) No 726/2004 of the European Parliament and of the Council. Additional information on the distribution of unregistered medicinal products available for compassionate use is available on the website of the State Agency of Medicines (hereinafter – the Agency) in the section “Medicinal products available for compassionate use”.
Important! The person gifting medicinal products shall ensure that patients treated with the gifted medicinal products may continue treatment with these medicinal products for as long as necessary or until the medicinal product is included on the schedule of reimbursable medicinal products and is available under the reimbursement system for the purchase of medicinal products.
The person gifting medicinal products shall ensure:
- that during the period of receipt of medicinal products not less than one year is left until the expiry date of the medicinal product, but if the total period of use of the medicinal product is less than one year, until the expiry date of the medicinal product is not less than half of the total period of use of the medicinal product;
- the collection and disposal of unused gifted medicinal products in accordance with the laws and regulations governing the circulation of hazardous waste;
- that the gift of medicinal products is issued with an invoice.
The gift of a registered medicinal product does not require a permit from the Agency. Control of the fulfilment of the requirements for the gift of medicinal products to medical treatment institutions shall be performed by the Health Inspectorate in accordance with Sub-paragraph 3.2 of Regulation No 309 of 9 July 2019 “By-laws of the Health Inspectorate”.
For more information
Regulation No 416 of 26 June 2007 “Procedures Regarding the Distribution and Quality Control of Medicinal Products”
Regulation No 220 of 27 March 2007 “Procedures for the Acquisition, Storage, Use, Registration and Disposal of Medicinal Products in Medical Treatment Institutions and Social Care Institutions”
Schedules of reimbursable medicinal products and lists of diagnoses and international non-proprietary names on the website of the National Health Service “Schedules of reimbursable medicinal products”
Regulation (EC) No 726/2004 of the European Parliament and of the Council
Agency's website section “Medicinal products available for compassionate use”.
Please note that the last amendments may not be included in linked translation. For legal reference please use Latvian version.
