PMCPA Guidance on temporary supply authorisations
ABPI Code of Practice for the Pharmaceutical Industry
The 2019 ABPI Code prohibits the promotion of medicines without marketing authorisations and requires that promotion is not inconsistent with the summary of product characteristics (Clauses 3.1 and 3.2). The prohibition on advertising prescription only medicines to the public has an exemption for vaccination campaigns approved by the health ministers.
The new regulations mean that changes were needed to the ABPI Code to ensure that if companies are to promote medicines with temporary supply authorisations then such activities are not inconsistent with the requirements of the ABPI Code. The approach is to ensure that the ABPI Code permits advertising of products with temporary supply authorisations. This is set out below in relation to application of the 2019 ABPI Code. The agreed 2021 ABPI Code takes account of the recent legislation.
2019 ABPI Code – additional guidance
If a complaint is received relating to matters recently permitted by the introduction of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020, in particular the advertising of medicines with temporary supply authorisations to health professionals and other relevant decision makers under Regulation 174 of The Human Medicines 2020 as amended and the company concerned has the relevant approval from the Ministers as set out in Regulation 280 as amended then by exception Clause 3 of the 2019 ABPI Code will not apply. Companies in such circumstances are expected to continue to comply with the Code. When a temporary supply authorisation has been granted, companies promoting such products to health professionals and other relevant decision makers must provide information similar to prescribing information as required by Clause 4.1 and ensure that material is not inconsistent with the temporary supply authorisation, the agreed product details and the agreed information for patients.
Similarly if a complaint is received relating to advertising to the public of medicines under Regulation 284 of The Human Medicines 2020 as amended and the company concerned has the relevant approval from the Ministers as set out in Regulation 292 as amended then by exception the limitation in Clause 26.1 of the 2019 ABPI Code will apply to vaccination and other campaigns as approved by the health ministers. Companies in such circumstances are expected to continue to comply with all other relevant requirements of the Code. In addition such campaigns should include a general reference to the reporting of side effects as it is unlikely that the requirements of Clause 26.3 will apply as the relevant material is not intended for patients taking a particular medicine.
* * * * *
The PMCPA position as outlined above has been discussed with the Advertising Standards Unit, Vigilance and Risk Management of Medicines, MHRA and the Code of Practice Appeal Board.
16 February 2021