Starting 9 February 2019, the medicinal products for human use (in accordance with Directive 2011/62 / EU in conjunction with Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83 / EC) must be equipped with additional security features and a device for detecting possible manipulation. In Germany, the prescription drugs for human use under the responsibility of the Paul-Ehrlich-Institut (PEI) (in accordance with Article 54a of Directive 2001/83 / EC) as well as parallel imports and their pack sizes may be marketed only if they comply with the provisions of Section 10 (1c) of the German Medicines Act (AMG). According to Article 5 (3) of Delegated Regulation (EU) 2016/161, the barcode shall be printed on the packaging by the manufacturer.
In addition to the exceptions listed in Annex I to Delegated Regulation (EU) 2016/161, the following groups of medicinal products under the responsibility of PEI are also exempted from the provisions of Section 10 (1c) AMG:
blood components excluded from the scope of the Directive in accordance with Article 3 (6) of Directive 2001/83/EC
tissue preparations, unless they are industrially produced tissue preparations within the scope of Directive 2001/83/EC
stem cell preparations for hematopoietic reconstitution from the bone marrow, peripheral blood or umbilical cord blood
advanced therapy medicinal products (ATMPs) within the meaning of Article 3 (7) of Directive 2001/83/EC.
Issues of trademark law remain unaffected by the above statements, as they are not subject to a marketing authorisation.
Purely nationally authorised drugs
For purely nationally authorised medicines, the requirements and instructions of the CMDh apply accordingly. By way of derogation, a national notification of change pursuant to Section 29 (1) AMG instead of a notification pursuant to Article 61 (3) of Directive 2001/83 / EC must be submitted if no use is made within the transitional period until 9 February 2019 of the possibility to include the standard declaration for recording the safety features in the product information as part of a procedure regarding the product information by adapting the template of the Quality Review of Documents Group (QRD) to the product information.
Medicinal Products Authorised by European Procedures
For the introduction of the security features and the device for detecting a possible manipulation please note the requirements and hints of the implementation plan of the European Medicines Agency (EMA) for medicines authorised by means of the centralised authorisation procedure or the implementation plan and the Question & Answers (Q & A) of the Co-ordination Group for Mutual Recognition and Decentralised Procedure-Human (CMDh) for MRP / DCP-approved medicinal products. Further information can be found in the European Commission's Question & Answer document (EC).
However, in the case of medicinal products for which the device against manipulation is not required to be applied in accordance with Article 54a (1) of Directive 2001/83/EC, devices for detecting potential manipulation may be installed voluntarily for the purposes of protection of marketing authorisation holders.
For pharmaceuticals that are marketed within the scope of the Medicines Act (Arzneimittelgesetz, AMG) and on whose external package security features and a device for detecting possible manipulation are to be installed pursuant to Section 10 (1c) AMG, the security features should always be printed directly on the secondary packaging.
In certain cases, the use of suitable adhesive labels is possible (see Section 2.21: Safety features for medicinal products for human use). Such cases are:
The European Commission points out that, for medicinal products whose packaging has been lawfully opened, the packaging must be resealed completely and no signs of the original and open anti-tampering device (ATD) should be visible (see paragraph 1.21: Safety features for medicinal products for human use).
If, due to the nature of the tamper-proofing device, it should not be possible to reseal the original packaging, the reboxing may be considered as a suitable measure to implement the requirements of the Falsifying Medicines Directive and the requirements of Article 47a of Directive 2001/83 / EC.
It should be noted that the supervision of labeling of medicinal products is the responsibility of the competent national authorities.