The recent communication by the Irish Pharmaceutical and Healthcare Association (IPHA) serves as a timely reminder of the importance and scrutiny given to advertising compliance for healthcare products. Under EU Legislation, Directive 2001/83/EC as amended and Irish Legislation, Medicinal Products (Control of Advertising) Regulations, 2007 (SI541), in addition to the two IPHA codes linked below, Marketing Authorisation Holders (MAHs) have the responsibility to ensure compliance with standards and accepted practices of advertising for their products
In 2019 the HPRA introduced a new type of visit to MAHs which enables it to review advertisements with the MAH representatives at their premises. Recently, the IPHA posed a series of questions to HPRA about such visits and how they are managed. The following key points identify how the visits are managed:
The HPRA contact the MAH and advise that it wishes to perform an advertising review at their office. MAHs are selected on a risk basis…presumably based on product(s)
- recently authorised
- recently switched
- with significant warnings or addition of new warnings
- with a narrow therapeutic indication and criticality of correct dosing
- associated with serious safety variations approved
- from MAHs with valid complaints upheld against them
- associated with serious adverse reactions
- specific advertising concerns
There is no fee for such visits.
The visits are akin to HPRA’s standard desk-top surveillance activities and companies are expected to comply with the advertising review visits.
There is no formal visit report issued to the MAH. However, following the two visits that were performed in 2019, the HPRA issued a letter to the MAHs stating the outcomes of the reviews and requested certain follow-up actions to be completed. This is not unlike what presently occurs in the standard HPRA desk-top review process
The HPRA review the compliance status of advertisements and promotional material of all, or some, of the company’s products.
The visits are intended to review advertisement compliance in a more efficient manner where any issues pertaining to advertisements and product promotion can be resolved quickly.
In preparation for such a visit, PharmaLex recommends that MAHs
- Confirm and ready the Scientific Service in charge of information about its medicinal products.
- Retain copies of all advertisements, persons addressed, dissemination method, date of first dissemination and have this information available for the HPRA if required.
- Ensure all advertising complies with national legislative requirements and IPHA codes*
- Verify that relevant employees and medical representatives are adequately trained & fulfil their obligations*
- Supply the HPRA with all information on the product advertisements reviewed.
*If you would like further information or wish to discuss how PharmaLex can support you with advertising compliance, please connect with us on +353 1 846 4742 or email us at email@example.com.