S.I. No. 49/2021 - European Union (COVID-19 Vaccines Export Authorisation) Regulations 2021

1. Doses Distributed in the EU to Date

Information on the number of vaccine doses of goods covered by Commission Implementing Regulation (EU) 2021/111 distributed in the Union since 1

st

December 2020, broken down by Member States as well as information on the number of vaccine doses of goods covered by this Regulation distributed in Northern Ireland since the entry into force of the Regulation.

Vaccine manufacturers that have concluded an Advance Purchased Agreement with the EU are required to submit the following information with their first application for an authorisation

Relevant data concerning their exports in the three months prior to the entry into force of the Regulation. This information shall include the volume of exports of COVID-19 vaccines, the final destination and final recipients and a precise description of the products.

Manufacturers shall provide this information electronically to the European Commission at

SANTE-PHARMACEUTICALS-B4@ec.europa.eu

and the Department of Enterprise, Trade and Employment at

exportcontrol@enterprise.gov.ie

Failure to provide this information may result in the refusal of export authorisations.

2. Declaration

I, the undersigned, certify that the information provided in this application is true and given in good faith.

Name of applicant (block capitals)

Signature

Date

Position in the Company

Telephone Number

Email Address

Please type the required information and return a scanned copy of the signed form to the

Department of Enterprise, Trade and Employment at

exportcontrol@enterprise.gov.ie

Explanatory note to the export authorisation application form

The completion of all the boxes is mandatory except when stated otherwise.

Box 1

Exporter details

Full name and address of the exporter for whom the authorisation is issued and EORI number if applicable.

TARIC additional code of manufacturer as defined in Annex II to the Commission Implementing Regulation.

Box 2

Final recipient

Full name and address of the final recipient of the goods, if known at the time of issuance and EORI number or equivalent, if applicable. If the final recipient is not known at the time of issuance, the field is left empty.

Box 3

Destination Country

2-letter geonomenclature code of the country of destination of the goods for which the authorisation is issued.

Box 4

Commodity Code

The numerical code from the Harmonised System or the Combined Nomenclature under which the goods to export are classified when the authorisation is issued.

Box 5

Description of goods

Plain language description precise enough to allow identification the goods.

Box 6

Quantity

The quantity of goods measured in the unit declared in box 7.

Box 7

Unit

The measurement unit in which the quantity declared in box 8 is expressed. The units to use are the number of vaccine doses.

Box 8

Location

If the goods are located in one or more Member States other than Ireland, please indicate that fact by including the geonomenclature code of the Member State where the goods are located. If the goods are located in Ireland, this box must be left empty.

Box 9

Doses Distributed in the EU to Date

Information on the number of vaccine doses of goods covered by Commission Implementing Regulation (EU) 2021/111 distributed in the Union since 1st December 2020, broken down by Member States as well as information on the number of vaccine doses of goods covered by this Regulation distributed in Northern Ireland since 30th January 2021.

Box 10

Declaration

Declaration that the information provided in the form is true and given in good faith.

EXPLANATORY NOTE

(

This note is not part of the instrument and does not purport to be a legal interpretation

.)

These Regulations give full effect to the transparency and authorisation mechanism for COVID-19 vaccines contained in Commission Implementing Regulation (EU) No 2021/111 regarding making the exportation of certain products subject to the production of an export authorisation.

The Regulations provide that an export authorisation shall be required for the export of vaccines against SARS-related coronaviruses falling under CN code 3002 20 10, as well as active substances including master and working cell banks used for the manufacture of such vaccines.

The Regulations create offences for breach of the Commission Implementing Regulations or for failure to comply with the directions of competent authorities of the State with regard to implementation of the export authorisation and provides for appropriate penalties.

1 OJ No. L 31 I, 30.01.2021, p.1

1 OJ No. L 31 I, 30.01.2021, p.1

3. Destination Country

4. Commodity Code

5. Description of the goods

6. Quantity

7. Unit

8. Location

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

12

th February,

2021.

I, LEO VARADKAR, Minister for Enterprise, Trade and Employment, in exercise of the powers conferred on me by Section 3 of the European Communities Act (No. 27 of 1972) and for the purpose of giving full effect to Commission Implementing Regulation (EU) 2021/111 of 29 January 2021

1

, hereby make the following regulations