Good Practice guidelines

Good Manufacturing Practice (GMP) guidelines

Part I – Basic Requirements for Medicinal Products

Chapter 1 – Pharmaceutical Quality System (published 9.4.2021.)
Chapter 2 – Personnel (published 9.4.2021.)
Chapter 3 – Premise and Equipment (published 9.4.2021.)
Chapter 4 – Documentation (published 9.4.2021.)
Chapter 5 – Production (published 9.4.2021.)
Chapter 6 – Quality Control (published 9.4.2021.)
Chapter 7 – Outsourced activities (published 9.4.2021.)
Chapter 8 – Complaints and Product Recall (published 9.4.2021.)
Chapter 9 – Self Inspection (published 9.4.2021.)

Part II – Basic Requirements for Active Substances used as Starting Materials

Basic requirements for active substances used as starting materials (published 9.4.2021.)

Part III – GMP related documents

Site Master File (published 9.4.2021.)
Q9 Quality Risk Management (published 8.9.2025.)
Q10 Note for Guidance on Pharmaceutical Quality System (published 9.4.2021.)
MRA Batch Certificate (published 9.4.2021.)
Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use (published 9.4.2021.)
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (all language versions are available here).(published 9.4.2021.)
Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials) (published 9.4.2021.)

Annexes

Annex 1 – Manufacture of Sterile Medicinal Products (published on 3.11.2023.)
Annex 2 – Manufacture of Biological active substances and Medicinal Products for Human Use (published 9.4.2021.)

Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.

Annex 3 – Manufacture of Radiopharmaceutical (published 9.4.2021.)
Annex 4 – Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products (published 9.4.2021.)
Annex 5 – Manufacture of Immunological Veterinary Medicinal Products (published 9.4.2021.)
Annex 6 – Manufacture of Medicinal Gases (published 9.4.2021.)
Annex 7 – Manufacture of Herbal Medicinal Products (published 9.4.2021.)
Annex 8 – Sampling of Starting and Packaging Materials (published 9.4.2021.)
Annex 9 – Manufacture of Liquids, Creams and Ointments (published 9.4.2021.)
Annex 10 – Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation (published 9.4.2021.)
Annex 11 – Computerised Systems (published 9.4.2021.)
Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products (published 9.4.2021.)
Annex 13 – Manufacture of Investigational Medicinal Products (published 9.4.2021.)
Annex 14 – Manufacture of Products derived from Human Blood or Human Plasma (published 9.4.2021.)
Annex 15 – Qualification and validation (published 9.4.2021.)
Annex 16 – Certification by a Qualified Person and Batch Release (published 9.4.2021.)
Annex 17 – Parametric release (published 9.4.2021.)
Annex 19 – Reference and Retention Samples (revised and published on 18.08.2026, applicable as of 24 September 2026)

Part IV – Good Manufacturing Practice Guidelines specific to Advanced Therapy Medicinal Products

Standardised GMP forms

Manufacturing authorisation for medicines (update on 5.6.2025.)
GMP certificate (update on 28.1.2026.)
GMP Inspection Report Format (published 16.4.2021.)

Good Distribution Practice guidelines

Guidelines on Good Distributive practice for medicinal products for human use (published on 22/7/2026.)

Standardised GMP forms

GDP certificate for medicine for human use (update on 16/4/2025)
GDP certificate for active substance (published on 12/10/2020)
GDP Inspection Report Format (published on 12/10/2020)
Wholesale authorisation for medicines for human use (Updated on 04/6/2025)

Good Clinical Practice guidelines

Guideline for Good Clinical Practice (published on 31/10/2025) (Note: These guidelines are published in the Montenegrin language)
Clinical Investigation of Medicinal Products in the Paediatric Population (published on 28/01/2014.)

Good Pharmacovigilance Practice Guidelines

In accordance with the Law on medicines, Good Pharmacovigilance Practice Guidelines are applied in the field of pharmacovigilance, which are available on the website of the European Medicines Agency (EMA)

Guidelines of good distribution practice for active substances

Guidelines of good distribution practice for active substances used as starting materials in veterinary medicinal products (“Official Gazette of Montenegro”, No. 22/26)

Guidelines of good distribution practice for active substances for medicines for humane use (published on 22/07/2026

Compilation of Union procedures on inspections and exchange of information