Implementation of the safety features in medicinal products for human use

Transcription

1 Translation of the responsibility of APIFARMA (not official) Information Circular N.º XXX/CD/cód. class. Date: DD/MM/YYYY Subject: For: Implementation of the safety features in medicinal products for human use Disclosure in general terms Contact: Centro de Informação do Medicamento e dos Produtos de Saúde (CIMI); Tel ; Fax: ; cimi@infarmed.pt; Linha do Medicamento: The requirement of placing safety features (anti-tampering device and unique identifier) on the packaging of certain medicinal products in order to allow the detection of falsified medicines in the legal supply chain and the identification of an individual packs was introduced by Directive 2011/62/EU, "Falsified Medicines Directive" and has to be implemented by February 09, This implementation will require adaptation of all the stakeholders, from the manufacturers to the supplying the medicines to the public, with special emphasis on the need of acquisition of new equipment that allow the placement and reading the unique identifiers and the adjustment of procedures regarding the verification of the safety features and decommission of the unique identifiers. The Delegated Regulation (EU) 2016/161 of October 2, 2015, supplementing the rules of the Directive and is directly applicable in the national legal order, establishes detailed rules for the safety features appearing on the packaging of medicinal products for human use defining which medicines should provide them, the characteristics and technical specifications of the unique identifier, the modalities for the verification of the safety features and decommissioning of a unique identifier and the characteristics of the repositories system. The practical application of the Delegated Regulation will oblige, in some aspects, the approval of legislation that adapts the safety features system to the specificities of the national reality of 1/7

2 prescription and dispensing medicines circuit and ensures the adequate supervision of the system and its accessibility by the regulatory authorities, which is currently underway in INFARMED, IP While this does not occur, and in order to clarify the main issues related to this system, and with a view to its implementation [INFARMED I.P.] clarifies the following: A. Scope of application of safety features The medicinal products which shall bear safety features on their packaging are: - All medicinal products subject to prescription, unless included in the list set out in Annex I to the Delegated Regulation (EU) 2016/161, of 2 October 2015; - All medicinal products not subject to prescription included in the list set out in Annex II to the Delegated Regulation (EU) 2016/161, of 2 October 2015; The verification of the authenticity of safety features and decommissioning of a unique identifier shall be carried out by entities legitimately acting on the national market, where applicable, regarding the medicinal products with a marketing authorization (MA) in Portugal and regarding the medicines from other Member States through Exceptional Use Authorization. The verification of the authenticity of safety features and decommissioning of a unique identifier must be carried out, in accordance with the aforementioned Delegated Regulation and the future national legislation on this matter, by manufacturers, wholesale distributors of medicines, community pharmacies and hospital pharmacies integrated in public and private healthcare institutions. B. Establishment of the Unique Identifier Article 4 subpragraph (b) point (iii) of the above-mentioned Delegated Regulation allows Member States to require the placing of a reimbursement number or other national number identifying the medicinal product as an integral part of the unique identifier. 2/7

3 The marketing authorization registration number of the medicinal product assigned by INFARMED, I.P. allows the identification of the medicine throughout all circuit, from manufacturing at the moment of supply to the public and for the reimbursement purpose. The marketing authorization registration number is therefore an essential number throughout the national drug system and must be included in the unique identifier, otherwise the entire system for the supply of medicinal products at national level will suffer serious constraints and because of that the adaptations to be required to all stakeholders being even bigger and more complex. Equally important, for the purposes of legal certainty and development of computer systems, is to determine where the marketing authorization registration number is stored inside the unique identifier. Having been made public the intention of the part of some national manufacturers to adopt the GTIN (Global Trade Item Number) as the product code [Article 4 (b) (i) of the Delegated Regulation], which makes it technically impossible to include the marketing authorization registration number in this code, because of its size, it is necessary that the registration number be placed as additional information in the fifth position within the unique identifier. Thus, the unique identifier must contain the following elements, in the following order: 1) The product code; 2) The serial Number; 3) The batch number; 4) The expiry date; 5) The registration number. 3/7

4 It should also be clarified that the legislation on labeling, in particular that provided for in Article 105 of Decree-Law no. 176/2006 of 30 August as amended will run, with no alterations, even after the new regulation on safety features entered into force. It therefore implies that the printing of the marketing authorization registration number in human readable format may continue to be carried out under the legal terms currently in force, not being mandatory its placement close to the other elements provided for in article 7 of the Delegate Regulation, together with the two-dimensional bar code. C. Extension of the scope of application of anti-tampering devices Manufacturers may voluntarily place the anti-tampering devices in packaging of medicinal products which are not covered by the Delegated Regulation (UE) 2016/161 of Commission of 2 October Where placing or removing the anti-tampering devices affects the container and its closure system, the marketing authorization holder (s) of the medicinal product shall submit the respective variation application to the MA, gathering all available information on the antitampering device and the manner in which this device affects the container and its closure system. If the anti-tampering device does not affect the container or its closure system, or if it is placed in the outer packaging, no regulatory procedure is required unless the device affects readability, in which case a notification has to be submitted. Removal of the anti-tampering device from medicinal products packaging for which this device is part of approved MA file but which do not fall within the scope of the Delegated Regulation is not mandatory. 4/7

5 D. Regulatory requirements resulting from the introduction of safety features on medicinal products packaging For the purpose of regulatory changes resulting from the introduction of safety features on the packaging of medicinal products, marketing authorizations holders may submit a notification to INFARMED, I.P. with the revised QRD template, pursuant to art. 31, no. 4 of Decree-Law no. 176/2006, of August 30, as amended. Alternatively, if a regulatory procedure affecting the product information (Renewal, Variation II, Variation IB or Variation IA) occurs until 2019, this procedure may be used by the MA Holders to present the the revised QRD template and confirming the implementation of the safety features. The inclusion of safety information in the labeling of the medicinal product does not imply that the safety features have already been effectively implemented on the labeling of the medicinal products placed or to be placed on the market, meaning only that the product information has been updated providing the necessary amendments arising from the implementation of the Delegated Regulation. New packaging may be placed on the market with the new devices as packaging lines being upgraded and the repositories system being operational For further clarification on the regulatory issues, it is recommended to consult the implementation plan for the introduction of the safety features on the packaging, prepared by the CMDh, on the website of the European Medicines Agency, through the following link E. Transitional period Medicines should only have unique identifiers when, preferably in Portugal, there is already a national repositories system in operation. However, its placement on the packaging before that 5/7

6 fact is allowed, on a voluntary basis, and the Parties must ensure the upload of the unique identifiers into the repositories system when the system is ready for production. The Parties may include one-dimensional codes (eg bar code 39), together with the unique identifier, provided that they have no impact on the readability of the outer packaging. Thus, it is possible for any manufacturer to keep the bar code 39 in a package which already has the unique identifier. The removal of the bar code 39 (currently used to identify the medicines vis-à-vis different entities of the circuit) from packaging is not possible until the repositories system being fully functional and the Delegated Regulation (EU) 2016/161) being applicable, on the February 9, 2019, since it is only after that date that Parties have a legal obligation to have their IT systems prepared and adapted to the new identification of medicines introduced by the safety features. It is important to recall that, according to art. 48 of the Delegated Regulation, Medicinal products that have been released for sale or distribution without the safety features in a Member State before the date in which this Regulation becomes applicable in that Member State, and are not repackaged or relabelled thereafter, may be placed on the market, distributed and supplied to the public in that Member State until their expiry date. The MVO Portugal - Portuguese Association for the Verification of Medicines, created under art. 35 (1) (b) of the Delegated Regulation, as well as all Parties operating in the national medicines supply chain must initiate the necessary actions so that their operational procedures and IT systems are in operation and adapted to the new reality on February 9, 2019, in order to avoid any constraints on the supply of medicines in Portugal from that date. More attention is being given to the need to set up and have the national repositories system in place as soon as possible in order to be able to test all stakeholders connections to this system and its full operation by the end of /7

7 The INFARMED, I.P. together with the European bodies and working groups will continue to provide all the necessary information and to promote the articulation between the various Parties in this field. The INFARMED, I.P Board 7/7