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In accordance with the Delegated Regulation, safety devices (unique identifier and tamper-proof device (DCM)) must appear on the packaging of medicinal products for human use which are subject to medical prescription, unless listed in annex I of the Regulation, and those not subject to medical prescription included in annex II.
Notwithstanding that the AEMPS specifically mentions in its note that the provisions of the Delegated Regulation must be included in the corresponding legal regulation, the note aims to provide some recommendations to keep in mind for those medicines that are being placed on the market already and from now on.
The recommendations apply to the packaging of authorized medicinal products whether they are effectively placed on the market or not, as follow:
- National Medicine Code
Although the Delegated Regulation does not require it, Spain has decided to include as an additional requirement to the composition of the unique identifier (UTI) a national code (CN), whose purpose still needs to be decided, as it can be used as a national reference for reimbursement or simply as a national identification number.
Likewise, outer packaging printing requirements will be maintained.
- Appropriateness of the labelling of authorized medicinal products at national level:
The AEMPS provides for two different procedures for the adequacy of the labelling of medicinal products depending on the changes that entails the introduction of the safety device:
A) A notice shall be sufficient when:
a. the device is included in a blank space of the container; or
b. it only requires the removal of information that is repeated elsewhere in the container, or
c. the inclusion of the device requires the relocation of content without affecting relevant aspects of design such as font size, separation spaces, line spacing, etc.
In these cases, it is only required to upload the new layout design in the computer application RAEFAR and via electronic sequence NeeS / eCTD. This procedure will not entail any additional costs, nor require prior authorization by the AEMPS and shall provide users with an acknowledgement of receipt. Marketing Authorization Holders (MAH) which have already submitted layout variations, are only required to upload the new layout in the electronic app.
B) Besides notifying, it will be necessary to submit the new layout when:
a. it removes prior authorized content information by the AEMPS, and/or
b. there is a reorganization of the packaging that affects relevant aspects of design such as font size, spaces of separation, line spacing etc., and/or
c. it affects the readability of the packaging in any way, and/or
d. the new layout includes design changes not related to the implementation of safety devices such as a change of logo, colors, font, inclusion of pictograms, etc.
The request for the inclusion of tamper-proof devices for medicines with no outer packaging shall be accompanied by the corresponding modification of the module 3 regarding quality.
- Appropriateness of the labelling of medicines authorized by European procedures
Medicines authorized by mutual recognition procedure and / or decentralized procedure shall follow the same procedure as in the previous section, but in the corresponding notification tab ’61 (3) safety devices’. Any additional changes, beyond the inclusion of the safety device, must be submitted through the usual procedure of notification and pay the relevant fees.
- Guarantee of scanning
All medicinal products released to be sold or distributed with the built-in unique identifier must be introduced in the repository, in order to ensure faultless scanning as of February 9, 2019.
Those who have been previously released until then, without safety devices, may continue on the market until its expiry date.
- Pre-serialization
Manufacturers may use containers already pre-serialized by a third party, as long as:
a) There is a written contract setting the respective responsibilities; and
b) The manufacturer verifies the capacity of the third party to comply with the regulation.
- Current and future codes
At the national level, during the period of integration of the Regulation, both the two-dimensional bar code demanded by European regulations and the barcode included in precinct coupons can co-exist. The AEMPS reserves the right to unify both codes in the future.