2. Scientific discussion
2.10. Product information
User consultation
The results of the user consultation with target patient groups on the package leaflet submitted by the applicant show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use.
Labelling exemptions
The following exemptions from labelling and serialisation requirements have been granted on the basis of article 63.3 of Directive 2001/83/EC. In addition, the derogations granted should be seen in the context of the flexibilities described in the Questions and Answers on labelling flexibilities for COVID-19 vaccines (EMA/689080/2020 rev.1, from 16 December 2020) document which aims at facilitating the preparedness work of COVID-19 vaccine developers and the associated logistics of early printing packaging activities. The ultimate goal is to facilitate the large scale and rapid deployment of COVID-19 vaccines for EU citizens within the existing legal framework.
EU packaging specific derogations
a) Outer and immediate labelling in English only (from start of supply until end 2021)
Outer and immediate labelling will be provided in English only for all EU Member States, as well as Norway and Iceland.
Country/language specific outer/immediate labelling shall be provided in all EU languages by beginning 2022.
This exemption is justified on the necessity to provide maximum flexibility of supply and speed of
vaccine production/deployment due to the ongoing pandemic. Production of different vaccine packs in different languages will significantly reduce the supply chain efficiency. The multiple changes on packaging lines will result in significant time and capacity losses and would slow down the rapid deployment of COVID-19 vaccines. The
use of
unified English-only pack components will allow the vaccine to be distributed across multiple countries simultaneously.A QR code and URL printed on the outer carton, QR card and the patient information leaflet will provide access to the product information in the national language(s).
b) Printed package leaflet in English only (from start of supply until end 2021)
A printed package leaflet (PL) will be provided in the national language(s) for those MSs that require so. All other MSs, that have granted a temporary exemption for an English-only PL, will receive the English printed PL. Moreover, the MAH shall contact MSs directly to agree on the exact numbers of PLs to be distributed in line with the published Q&A on labelling flexibilities.
A QR code and URL printed on the outer carton, QR card and the PL will provide access to the package leaflet in the national language(s).
Moreover, the MAH shall contact MSs directly to agree on the exact numbers of PLs to be distributed in line with the published Q&A on labelling flexibilities.
The MAH shall provide a printed package leaflet in all EU languages by beginning 2022. The MAH shall engage with the National Competent Authorities (other than the 6 mentioned above) to discuss and speed up the provision of PLs in the respective national language(s) of the MSs concerned. The MAH shall also contact MSs directly to agree on the exact numbers of PLs to be distributed, again in line with the published Q&A on labelling flexibilities.
c) Outer and immediate labelling. Temporary omission of certain particulars on the labelling (from start of supply to end 2021).
The following exemptions are temporarily agreed for the outer labelling. These exemptions are justified on the necessity to label batches ahead of time.
Outer carton and printed package leaflet
o Common name: 'COVID-19 vaccine (Ad26.COV2-S (recombinant))' (initially proposed), instead of 'COVID-19 vaccine (Ad26.COV2-S [recombinant])' (agreed during evaluation [with square brackets]). This exemption on the common name is temporarily agreed for the outer carton and the printed package leaflet for the first batches until end 2021.
Outer carton
o Statement of the active substance. Due to the expedited development, product specifications were not final at the early stage of printing packaging materials. Therefore, the statement of active substance will be fully omitted from the outer carton for the first batches until end 2021.
o Abbreviated MAH name and company logo
d) EU Marketing Authorisation number (from start of supply to end 2021)
The inclusion of the EU Marketing Authorisation number in the labelling will be implemented with the switch to national variants of the EU packaging by beginning 2022. The MA number will be available on the electronic version of the EUPI.
e) Blue Box (from start of supply to end 2021)
granted to omit it from the outer carton.
The information normally provided in the market specific packaging Blue Box area of the carton will be provided as an electronic version on the website (via the QR code/URL) under the country page, if required by the National Competent Authorities in each MS. The QR code and URL address (website) will be made available on the PL, carton box and QR card.
The Blue Box will be included in the updated carton component when national variants of the packaging will be possible by beginning 2022.
f) QR card (from start of supply to end 2021)
One QR card will be supplied in each carton box. The QR card will include a QR code and an URL address (website) that links to an electronic product information translated in all EU languages.
h) Manufacturers responsible for batch release (from start of supply to end 2021)
Due to the use of two manufacturers responsible for batch release for the supply of this vaccine in the EU, an exemption is requested for not indicating which is the manufacturer responsible for the release of the concerned batch in the printed package leaflet. This request is justified to meet capacity demands, and to ensure there is sufficient flexibility to accommodate for possible delays at some manufacturing sites or unavailability of release capacity.
Both manufacturers responsible for the batch release will be listed in the printed package leaflet. In addition, the following sentence: “For the specific manufacturer of the vaccine you have received, check the Lot number on the carton or vial and please contact the local representative of the Marketing Authorisation Holder.” will be included in the package leaflet for traceability purposes.
Exemption from the obligation of serialisation
- All EU Member States have accepted a temporary derogation from serialisation for the EU pack for a period of 3 months starting from the EC decision date.
- the MAH shall provide monthly progress reports on the serialisation: referring to details on the progress achieved in terms of ensuring compliance, e.g. proof of acquiring the relevant equipment, the date for the validation, the proof of contract to connect to the European Medicines Verification
Organisation;
- the MAH shall provide additional mitigating measures, e.g. immediate reporting of any stolen product during the period of exemption, reporting of any counterfeit or falsified vaccine in the EU or third countries in the legal supply or internet, reconciliation of product distributed and used in the respective territory;
- the MAH should also consider technical solutions to the serialisation due to the risk of falsification.
The following safety features were endorsed:
• proprietary name Janssen varnish on via label and folding box;
• digital watermark on vial and folding box;
• hidden image on folding box;
• glues anti tamper evident flaps.
Quick Response (QR) code
A request to include a QR code in the labelling and the package leaflet for the purpose of providing information to Healthcare Professionals and vaccine recipients has been submitted by the applicant and has been found acceptable.
The following elements have been agreed to be provided through a QR code:
Statutory information
• Approved regulatory information, including the patient information leaflet (PIL) and Summary of Product Characteristics (SmPC);
• Vaccination Card;
• Blue Box information as required by each Member State;
• Storage, dosing and administration brochure;
• Access to the national reporting systems for adverse events websites;
• Contact numbers for more information on the COVID-19 vaccine including product quality complaints;
• Link to the COVID-19 vaccine Janssen on the EMA website.
Additional monitoring
Pursuant to Article 23(1) of Regulation No (EU) 726/2004, COVID-19 Vaccine Janssen (adenovirus serotype 26 vector encoding sars-cov-2 spike glycoprotein (Ad26.COV2-S)) is included in the additional monitoring list as it contains a new active substance which, on 1 January 2011, was not contained in any medicinal product authorised in the EU and it is approved under a conditional marketing
authorisation.
Therefore, the summary of product characteristics and the package leaflet includes a statement that this medicinal product is subject to additional monitoring and that this will allow quick identification of new safety information. The statement is preceded by an inverted equilateral black triangle.