Accession Requirements

PIC/S membership is open to GMP Inspectorates having an inspection system comparable to that of other PIC/S Members (Article 8 of the PIC Scheme). The main conditions are to have a law on medicinal products, a GMP Guide equivalent to that of PIC/S (or the EU GMP Guide), a GMP Inspectorate, which fulfils PIC/S quality system requirements and experienced GMP Inspectors.

Requirements for Membership

The exact requirements can be seen from the Audit Checklist (see below "Related Documents") which is applicable to both assessments and reassessments under PIC/S.

Indeed, existing PIC/S Participating Authorities are also reassessed for equivalence on a regular basis. This ensures that both new applicants and older members fulfil the same requirements.

Financial Costs

Due to changes in the PIC/S membership fee structure applicable as of 2025, prospective Applicants and Pre-Applicants are invited to contact the PIC/S Secretariat to obtain more information on applicable fees. Please note that – in addition to the annual fee – PIC/S membership implies other costs, such as regular participation in the PIC/S Committee meetings (1-2 per year), Seminars (1 per year), Expert Circle meetings (2-3 per year) and Joint Visits. All these events take place in other PIC/S countries around the world and last from 1 to 3 days each. A corresponding travelling budget should thus be ensured.

Attendance of Meetings, Seminars & Expert Circles

Non-PIC/S Agencies, which have applied for accession, can attend PIC/S Committee meetings. They can also attend PIC/S Seminars and Expert Circle meetings. They are encouraged to participate in these activities, as it will allow them to get familiar with the PIC/S family. They have also the possibility to contact other PIC/S Members directly. They can for example visit them in order to exchange information on their GMP system and their way of carrying out inspections.