Accession

The Accession Procedure as such is a time-consuming exercise. This is due to the fact that it will take you some time to complete your application and provide all the necessary translations of the supporting documents. In addition, your Inspectorate may have to take measures to fulfil PIC/S requirements (e.g. regarding its quality system, the training of Inspectors, etc.) and must allow sufficient time for the national industry to comply with the PIC/S GMP Guide. Finally, the PIC/S Committee, which will deal with your application, meets only twice a year. Please note that the maximum deadline to successfully complete the accession process is six years.

An Authority applying for participation in the PIC Scheme ( “Applicant”) should address itself first to the Secretariat preferably by e-mail.  The Secretariat shall provide the Applicant with all appropriate information and documents, in particular the Questionnaire and the Audit Checklist (see below "Related Documents"), information on (i) fees; (ii) total timeframe to join the Scheme and (iii) the Applicant’s responsibilities.

A membership application will only be considered complete and the assessment process will only start once the complete application and all supporting documents have been received and the Applicant has paid the application fee.  The Secretariat will inform the Applicant about the starting date of the procedure and remind the Applicant of the 6-year timeframe.

In addition, during the whole assessment process, Applicants will have to pay an annual fee corresponding to 80% of the membership fee paid each year by PA.

Depending on the size and the complexity of the Applicant’s organisation and application, the PIC/S Committee shall appoint (i) one Rapporteur and (ii) one or several Co-Rapporteur(s) to review and evaluate the membership application.

The final evaluation and decision is made by the Committee.

If an Applicant has been assessed or reassessed by two other PIC/S PA under other programmes within the past 5 years, the PIC/S Committee may decide on a partial assessment based on the review by the Rapporteur of the evaluation reports issued by these PA.  The Applicant shall share these reports with the PIC/S Committee.  In this case, the on-site assessment shall be waived.  If necessary, the Committee may however decide on a follow-up visit to check the implementation of possible recommendations made by the Rapporteur.

The Accession Procedure is described in detail in the Accession Guidelines (see below "Related Documents").