Lexparency.org
Deutsch
Español
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015
Supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
(Text with EEA relevance)- Recitals
CHAPTER I — SUBJECT MATTER AND DEFINITIONS- CHAPTER II — TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER
- CHAPTER III — GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES
- CHAPTER IV — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS
- Article 14 — Verification of the two-dimensional barcode
- Article 15 — Record keeping
- Article 16 — Verifications to be performed before removing or replacing the safety features
- Article 17 — Equivalent unique identifier
- Article 18 — Actions to be taken by manufacturers in case of tampering or suspected falsification
- Article 19 — Provisions applicable to a manufacturer distributing his products by wholesale
- CHAPTER V — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS
- Article 20 — Verification of the authenticity of the unique identifier by wholesalers
- Article 21 — Derogations from Article 20(b)
- Article 22 — Decommissioning of unique identifiers by wholesalers
- Article 23 — Provisions to accommodate specific characteristics of Member States' supply chains
- Article 24 — Actions to be taken by wholesalers in case of tampering or suspected falsification
- CHAPTER VI — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY PERSONS AUTHORISED OR ENTITLED TO SUPPLY MEDICINAL PRODUCTS TO THE PUBLIC
- Article 25 — Obligations of persons authorised or entitled to supply medicinal products to the public
- Article 26 — Derogations from Article 25
- Article 27 — Obligations when applying the derogations
- Article 28 — Obligations when supplying only part of a pack
- Article 29 — Obligations in case of inability to verify the authenticity and decommission the unique identifier
- Article 30 — Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification
- CHAPTER VII — ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM
- Article 31 — Establishment of the repositories system
- Article 32 — Structure of the repositories system
- Article 33 — Uploading of information in the repositories system
- Article 34 — Functioning of the hub
- Article 35 — Characteristics of the repositories system
- Article 36 — Operations of the repositories system
- Article 37 — Obligations of legal entities establishing and managing a repository which is part of the repositories system
- Article 38 — Data protection and data ownership
- Article 39 — Access by national competent authorities
- CHAPTER VIII — OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS
- CHAPTER IX — OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES
- CHAPTER X — LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION
- CHAPTER XI — TRANSITIONAL MEASURES AND ENTRY INTO FORCE
- Final
- ANNEX I — List of medicinal products or product categories subject to prescription that shall not bear the safety features, referred to in Article 45(1)
- ANNEX II — List of medicinal products or product categories not subject to prescription that shall bear the safety features, referred to in Article 45(2)
- ANNEX III
- ANNEX IV