At Red Line we ensure that your business has the best Pharmacovigilance support in the industry

News Archive > News Story

Don't need Copy Approval? .... I don't think so!

The ABPI Code of Practice has been in effect since 1958 and pharmaceutical companies are expected to abide by the code, whether or not they are members of the ABPI. The Code reflects UK and EU legislation on the advertising of medicines and breaking the Code therefore, constitutes breaking the law.

Materials produced by pharmaceutical companies need to be reviewed, approved and certified by two signatories, one of which must be a pharmacist or medical physician.

It’s important to err on the side of caution and classify materials produced by a pharmaceutical company as promotional. This is deemed good practice, since something can be classified as ‘promotional’ not just by what the piece is, but by how it’s used and the user’s objective. Your involvement can change a non-promotional activity into a promotional one.

If your company produces material related to a specific product, albeit indirectly, it’s considered promotional and must comply with relevant advertising regulations.

Remember, even materials produced by agencies on your behalf, or at your request, are considered to be from the company. There is a misconception in the pharmaceutical industry that the Code applies to sales representatives and marketing departments.

So, let’s take a look at some less obvious areas where the Code may impact your business and where companies should be thinking about how to include copy approval within their procedures.

  • Letters or invitations to attend a meeting
  • Prescribing guidelines produced in collaboration with the NHS for the NHS
  • Responses to enquiries by staff who are not medical information
  • Letters to arrange appointments or interviews
  • Educational material
  • Product training courses or therapy area training
  • Any slides used for presentations to healthcare professionals
  • Meeting materials, including invitation, programme, welcome letter, posters, presentations, briefing for speakers, lecture notes or packs for attendees and the meeting report
  • Website content, particularly product specific websites

Its important to understand that any written information sent out by a representative is more than likely to be considered as promotional. As such, in companies that do not have their own representatives or sales force, any commercial staff should be considered in the same light.

A letter from medical information is not covered by the Code as long as it provides a specific and direct response to the enquirer that is accurate, fair, objective and non-promotional. It is therefore always good practice to pass any product enquiries on to medical information. However, using a letter from medical information to facilitate further discussion means it is being used in a promotional way.

Having access to a copy approval specialist for general advice and guidance can go a long way to ensuring your company’s marketing strategy is clear and your reputation is protected.

Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
METS Contact us on 0330 1359 436 Copyright © 2020 Red Line Ltd (Registered in England & Wales : 07395811)
[LIVE: 310] Build by Red Line IT