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

In line with a decision by the PIC/S Committee which entered into force on 11 June 2021 the applicable fees for the financial year 2022; then as from the financial year 2023 are:

For Members:

The annual ordinary membership fee is CHF 9,200 (Swiss Francs) for 2022; then CHF 9,900 as from 2023. It is paid by full Members. Please note that PIC/S membership implies slightly higher costs, as regular participation in the PIC/S Committee meetings (2 per year), Seminars (1 per year), Expert Circle meetings (3 per year) and Joint Visits (2 to 3 per year) is normally expected from Members. 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.

For Applicants:

Applicants have to pay a registration fee, equivalent to the annual ordinary membership fee (i.e. CHF 8,500 for applications lodged in 2021; CHF 9,200 for applications lodged in 2022; CHF 9,900 for applications lodged in 2023), which will be charged once all the complete application has been submitted to the PIC/S Secretariat. In addition, during the whole assessment process, Applicants will have to pay an annual fee corresponding to 80% of the annual membership fee paid by Members (i.e. CHF 7’500 for 2022; CHF 8’200 for 2023).

For Pre-Applicants:

Pre-Applicants do not have to pay a registration fee but during the whole pre-assessment process, Pre-Applicants will have to pay - similarly to Applicants - an annual fee corresponding to 80% of the annual membership fee paid by Members (i.e. CHF 7’500 for 2022; CHF 8’200 for 2023).

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.

Related documents

Document Reference date
pic/s guidelines for the pre-accession procedure PS W 12 2019 (Rev. 1) 2022
pic/s guidelines for accession PS W 14 2011 (Rev. 3) 2022
questionnaire for assessment PS W 01 2011 (Rev. 1) 2022
pic/s audit checklist PS W 01 2005 (Rev. 3) 2022
pic/s audit checklist - interpretation guide PS W 31 2019 2020
revised pic/s scheme PICS 1/95 (Rev 6) 2020
quality system requirements for pharmaceutical inspectorates PI 002-3 2007