We are pleased to provide you with this memorandum on regulatory requirements for distribution of training kits to health care professionals (HCP) free of charge in the light of laws and existing practice in the Republic of Lithuania.

Background iInformation

Based on the information provided to us, we understand that UAB “JOHNSON & JOHNSON” (Johnson), acting as the representative of the marketing authorisation holder (MAH) in Lithuania of medicinal product Plegridy 63 micrograms solution for injection in pre-filled syringe (Medicinal product) in Lithuania, would like to distribute to HCPs training kits comprised of an injection pen without active substance and an injection pad (Training kit) free of charge. The purpose of such distribution and the Training kit is to educate the HCPs working with multiple sclerosis patients so that they couldan train the patients who are prescribed with the Medicinal product to administer thait medicine properly. There is no intention to promote the Medicinal product or to induce to recommend or prescribe it.

In order to cooperate with national competent national authorities in good faith, Johnson, referred to the State Medicines Control Agency (Agency) for an opinion on how the Agency consviderws this Training kit in the light of national legislation and in what manner it is to be distributed to the HCPs.

The Agency replied to Johnson with a letter dated 2 June 2016 (Letter) by stating that distribution of the Training kit to the HCPs, in the light of Rules on Advertising of Medicinal Products, approved by the Order No V-1128 of the Minister of Health and dated 28 December 2006 (Rules on Advertising), distribution of the Training kit to HCPs could be considered asto be provision of gifts to the HCPs, which is prohibited. The Agency also indicated that the Training kit could be supplied to a health care organisation (HCO) free of charge as a donation in accordance with the provisions of the Law on Charity and Sponsorship or in other ways that are legally compliant.

According to the Ssummary of product characteristics of the Medicinal product (p. 111), before the first use of the Medicinal product, a doctor or nurse must show a patient (or his/her carer) how to prepare and inject the Medicinal product the right way. Johnson believes that this implies a duty on the part of the representative of the Medicinal product to educate the HCPs and supply the Training kits to them, as this would help the HCPsm to demonstrate to the patients how the Medicinal product is to be used. To our knowledge, Johnson prefers to distribute the Training kits directly to the HCPs working with multiple sclerosis patients during face -to -face visits and then collect them back for proper wastinge purdisposesal.