Problem
Analyze the factual situation in order to identify the relevant issues, explain the appropriate legal principles and apply them to the facts, and reason your conclusion.
On 1 September 2022, acting under Article 5 of Regulation (EU) 2015/479 on common rules for exports, the European Commission adopted Commission Implementing Regulation 2022/XYZ, which establishes a requirement of an export authorization for the export to third countries of certain Union goods in the meaning of Article 5(23) of Regulation (EU) No 952/2013, including the export of third-generation vaccines against monkeypox. The export authorization shall be granted by the competent authorities of the Member State where these vaccines are manufactured, and Member States are to define the content of the application form for an export authorization. The exportation of such goods is prohibited if the exporter is not able to produce a valid export authorization. The competent authorities of the Member States are allowed to deliver an export authorization only if it does not pose a threat to ensuring sufficient supplies of the vaccines in question in the Member States.
Due to the scarcity of monkeypox vaccines and the urgent need to ensure the adequacy of supply in the Union, the Commission adopted the Implementing Regulation under Article 8 of Regulation 182/2011. To date, it has not yet sought the opinion of the relevant committee.
Nordic Meds A/S, a Danish company, which is currently the only pharmaceutical company that manufactures third-generation vaccines against monkeypox, is concerned that its business opportunities in non-EU markets will be affected due to the Implementing Regulation.
Advise Nordic Meds A/S on whether there is any legal remedy available to it under EU Law to challenge Commission Implementing Regulation 2022/XYZ
You can say something like this to outline the memorandum:)
1) Article 263 TFEU sets out the principles and structure underlining annulment proceedings - 4 pivotal points that the Court examines when an action for annulment is brought:
a) Compliance with the time limit for bringing the action
b) The reviewability of the act
c) The standing of the applicant - where the applicable rules vary significantly depending on whether the application is classified as 'privileged', 'semi-privileged' or 'non-privileged'
d) The existence of possible grounds for the annulment of the act.