2. Scientific discussion
2.10. Product information
2.10.1. User consultation
A justification for not performing a full user consultation with target patient groups on the package leaflet has been submitted by the applicant and has been found acceptable, given the current urgent public health need for rapid development and approval of vaccines to prevent the global burden of disease associated with SARS-CoV-2 infection and COVID-19 disease, and because the product will always be administered by a healthcare professional.
The applicant is expected to thoroughly review and update the package leaflet in the light of the results from the user testing.
2.10.2. Labelling exemptions
The following exemptions from labelling 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)2 document which aims at facilitating the preparedness work of COVID-19
2 Available at https://www.ema.europa.eu/en/documents/other/questions-answers-labelling-flexibilities-covid19-vaccines_en.pdf, last consulted on 21 December 2021.
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
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 will be provided in all EU languages by 2nd quarter 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. Moreover, English only labelling will better help to manage a shortage situation in one country by using immediately the supply from another country.Additionally, a QR code and URL printed on the outer carton and the patient information leaflet (PL) will provide access to the product information in the national language(s).
b) Printed package leaflet
From the beginning of supply and until end of March 2021
No printed package leaflet (PL) will be supplied to EU MSs, including Norway and Iceland. During this time access to the national version of the PL will only be available via a QR code/URL printed on the outer carton and on vaccination reminder cards, where available. The company shall work with MSs on national solutions, if possible, where printed cards are not available.
This exemption is justified on the necessity to accelerate launch activities of the first batches of the vaccine following EC decision due to the ongoing pandemic.
From end of March 2021 until 2nd quarter 2022
The MAH shall supply as of end of March 2021 a printed package leaflet in the national language(s) of the following MSs: Belgium, Bulgaria, Croatia, Czech Republic, France and Greece. All other MSs, that have granted a temporary exemption for an English-only PL, will receive the English printed PL.This exemption is justified to minimise delays in release of the vaccine to countries as supply will be equitable across the EU markets. Production of PLs in different languages will significantly reduce the supply chain efficiency due to constraints at the print vendors and complex logistics. Keeping the number of different language printed PLs to a minimum increases the printing capacity, simplifies the logistics at the distribution hubs and facilitates a rapid deployment to multiple markets simultaneously.
In addition, a QR code/URL printed on the outer carton and the PL will provide access to the package leaflet in the national language(s).
The MAH shall ensure a 1:1 supply of printed PL to dose of vaccine. 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.
From 2nd quarter 2022
The MAH shall provide a printed package leaflet in all EU languages by 2nd quarter 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, as well as to agree on the exact numbers of PLs to be distributed 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 May 2021).
The following exemption is temporarily agreed for the outer labelling. This exemption is justified on the necessity to label batches ahead of time.
Outer carton
o Pharmaceutical form: ‘solution for injection’ (initially proposed), instead of ‘suspension for injection’
(agreed during evaluation) d) Statement of 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.
From end of May 2021
As of end May 2021 the statement of the active substance on the outer carton will be implemented as follows: `One dose (0.5 ml) contains not less than 2.5 × 108 infectious units´
Due to space constraints and in order to ensure readability it has been allowed to omit permanently the sentence: `Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein ChAdOx1-S´ from the carton.
e) EU Marketing Authorisation number (from start of supply to end of May 2021)
Due to the expedited development, the EU number was not available at the early stage of printing packaging materials, and hence it will not appear on the initial launch components.
The inclusion of the EU Marketing Authorisation number in the labelling will be implemented by end May 2021.
f) Blue Box (from start of supply to 2nd quarter 2022)
Due to the use of one unified pack across all the EU countries, an exemption for the Blue Box is requested for omission 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 Blue Box will be included in the updated carton component when national variants of the packaging will be possible by 2nd Quarter 2022.
2.10.3. 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).
• Traceability and Vaccination Reminder Card.
• Blue Box information as required by each Member State
Additional information
• Link to the national reporting systems for adverse events websites
• Local telephone numbers for safety reporting
• Product Quality Complaints via electronic reporting form to AstraZeneca
2.10.4. Additional monitoring
Pursuant to Article 23(1) of Regulation No (EU) 726/2004, COVID-19 Vaccine (ChAdOx1-S [recombinant]) 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.