Vinlab Pharma (Pty) Ltd. — EU GMP NCR (EudraGMDP) Findings

Following an on-site inspection at Vinlab Pharma (Pty) Ltd. in South Africa (10–13th April 2025) for the analytical testing (chemical and microbiological) of non-sterile dosage forms, specifically for Cannabis medical products (inflorescence), the draft post-inspection letter’s critical and major deficiencies were reviewed by the Inspectors' Review Group (IRG). The inspection aimed to evaluate the company's eligibility for EU GMP certification. The inspection resulted in the identification of four critical and three major deficiencies. The critical findings were concerned with Validation and Qualification activities and QC Chemistry and Micro analytical operations, whilst the major deficiencies were concerned with risk considerations and risk assessments, deviation management and IT systems and their back-ups with serious data integrity implications, amongst others. During the inspection it was confirmed that the company does not currently perform any analytical testing for products on the EU/EEA market. Based on these findings, the IRG concluded that EU GMP certification could not be granted, and a statement of non-compliance with GMP will be issued as per the Compilation of Union Procedures. Action taken/proposed by the NCA: Revocation of the marketing authorisation(s) Member States should consider refraining from initiating or authorizing marketing authorization applications that list this site as a finished product analysis site whilst the recommended non-compliance statement is issued and remains in place.