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14.1
14.1 Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by one person on behalf of the company in the manner provided for by this clause, subject to the provisions of the supplementary information to this clause where relevant. This person must be a registered medical practitioner or a pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a UK registered dentist.
The person certifying on behalf of the company must not be the person responsible for developing or drawing up the material.
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14.4
14.4 The names of those nominated as signatories as set out in Clauses 14.1 and 14.2, together with their qualifications, shall be notified in advance to
the Advertising Standards Unit, Vigilance and Risk Management of Medicines of the Medicines and Healthcare products Regulatory Agency and to the Prescription Medicines Code of Practice Authority. The names and qualifications of designated alternative signatories must also be given. Changes in the names of nominees must be promptly notified.
In accordance with Clause 14.4 companies are required to provide names and qualifications of their nominated signatories to the PMCPA and the Medicines Healthcare products Regulatory Agency (MHRA). When notifying the PMCPA of any changes it would be helpful to use the downloadable Nominated Signatory Form.
