6 Abridged Complaints Procedure

6.1 The case preparation manager may determine that the abridged complaints procedure will be followed in relation to a complaint or voluntary admission where: (i) the allegations fall within the Authority’s approved list for use of the abridged procedure (published on the PMCPA website) and (ii) it appears that the central facts will not be disputed and (iii) it is likely in the case preparation manager’s view that there has been a breach of the Code. The case preparation manager will notify the parties that the complaint is being handled through the abridged complaints procedure.

6.2 Where a complaint comprises multiple allegations, the complaint will follow the full complaints procedure if any of the allegations do not fall within the scope of the abridged complaints procedure.

6.3 If the complainant is not a pharmaceutical company, the case preparation manager may identify the clause(s) relevant to the allegation(s).

6.4 In the event that the case preparation manager does not agree that a clause cited by the complainant is relevant, the complainant will be informed with written reasons. If the complainant does not agree with the case preparation manager’s decision to remove a clause they may request that the matter is referred to an independent referee.

6.5 Upon receipt of a complaint, the respondent company has fifteen working days in which to conduct its investigation and respond in writing. An extension of time to respond may be granted at the discretion of the case preparation manager.

6.6 When the response from the respondent company is received, the case preparation manager must assess whether the response satisfies the following criteria:

• The respondent company accepts the breach(es) of the Code and provides a written undertaking that the activity or use of the material in question and any similar material (if not already discontinued or no longer in use) will cease forthwith and that all possible steps will be taken to avoid a similar breach of the Code in the future; and

• The respondent company confirms that, as a result of its investigation, it has not identified a systemic compliance issue in relation to the matter(s) alleged.

The undertaking must be signed by the managing director or chief executive or equivalent of the company or with their authority and must be accompanied by details of the actions taken by the company to implement the undertaking, including the date on which the material was finally used or appeared and/or the last date on which the activity took place.

6.7 If the case preparation manager assesses that the respondent company’s response does not satisfy the criteria in Paragraph 6.6, the case will follow the full complaints procedure, including the requirement for the company to provide a complete response to the matter of complaint. The case preparation manager may identify additional clauses at this stage, where appropriate to do so.