• Introduction

• Glossary

Part I – Basic Requirements for Medicinal Products

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

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

• Basic requirements for active substances used as starting materials

Part III – GMP related documents

• Site Master File
• Q9 Quality Risk Management
• Q10 Note for Guidance on Pharmaceutical Quality System
• MRA Batch Certificate
• Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use
• 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).
• Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

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

Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products,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

• Annex 4 – Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

• Annex 5 – Manufacture of Immunological Veterinary Medicinal Products

• Annex 6 – Manufacture of Medicinal Gases

• Annex 7 – Manufacture of Herbal Medicinal Products

• Annex 8 – Sampling of Starting and Packaging Materials

• Annex 9 – Manufacture of Liquids, Creams and Ointments

• Annex 10 – Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

• Annex 11 – Computerised Systems

• Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products

• Annex 13 – Manufacture of Investigational Medicinal Products

• Annex 14 – Manufacture of Products derived from Human Blood or Human Plasma

• Annex 15 – Qualification and validation

• Annex 16 – Certification by a Qualified Person and Batch Release

• Annex 17 – Parametric release

• Annex 19 – Reference and Retention Samples

Standardised GMP forms

• Manufacturing authorisation for medicines (published 16.4.2021.)

• GMP certificate (published 16.4.2021.)

• GMP Inspection Report Format (published 16.4.2021.)

• Guidelines on Good Distributive practice for medicinal products for human use (published on 12/10/2020.)
• GDP certificate for medicine for human use (published on 12/10/2020.)
• 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 (published on 12/10/2020.)

• Guideline for Good Clinical Practice (Note: These guidelines are published in the Montenegrin language and applicable from September 3, 2021)
• Clinical Investigation of Medicinal Products in the Paediatric Population (published on 28/01/2014.)
• Smjernice o sadržaju dokumentacije potrebne za dobijanje mišljenja Etičkog odbora (objavljene 24.9.2021. godine)

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)