This guide explains how a sponsor submits an Addition of a Member State concerned (a new country) under Article 14 CTR in CTIS for a trial that is already authorised in at least one other country.
You may submit an application for a new country approval only if all of the following are true:
- Initial application decisions completed: All countries that received the initial whole application (Art. 5) or staggered parts (Art. 11) have issued a final decision and at least one MSC authorised the trial
- No ongoing Part I or Part I+II substantial modifications in any approved country is active at the time of application for a approval of a new country
- Part II substantial modifications may be ongoing elsewhere; this does not block an an application for the approval of a new country
Roles and Responsibilities
- Sponsor: Prepares and submits the the application for the approval in a new country in CTIS; ensures content/format matches CTR Annexes and national requirements; manages RFIs within deadlines.
- The authorities that first approved the trial: Consolidates Part I considerations (if any) from the aMS and other MSCs; issues any AM-related RFI to the sponsor.
- The authorities that are approving the trial: Assesses Part II for the added territory; may provide Part I considerations (without reopening the Part I decision).
- National competent authorties and ethics committee: National assessors for Part II; may stipulate national specifics.
Timelines
- Validation + Assessment + Decision: up to 52 calendar days from submission date.
- If a request for information is issued: the overall procedure may extend by up to 31 calendar days.
- Considerations on Part I by the authorities that are approving the trial: up to Day 47 after submission; The authorities that first approved the trial can consolidate within 5 days thereafter.
- Upon sponsor’s request for information response: joint MSC review of additional information within 19 days.
Dossier Composition (What to Prepare)
Remember: Part I content is carried over from the current authorised dossier (read-only by the authorities that are approving the trial). You provide any required Part I translations and the full Part II package for the authorities that are approving the trial.
5.1 Form (administrative)
- Cover letter (structured)
- Fees: Proof of payment (sponsor obligation)
5.2 Part I (informative for the authroties that are approving the trial; not re-decided)
- Protocol (current authorised version), IB, IMPD/quality, safety, IMP labelling, etc.
- If translations of Part I elements are required by the aMS, supply them (per national practice).
5.3 Part II (assessed by the authorities that are approving the trial) — typical contents
- Informed Consent Form (ICF) + participant information sheets (aMS language).
- Recruitment materials (posters, ads, web copy) in aMS language.
- Data protection information (GDPR notices, national clauses as applicable).
- PI CV(s) and site suitability documentation.
- Investigator/site agreements, financial arrangements, compensation to subjects.
- Insurance/indemnity certificate wording compliant with aMS requirements.
- Lay summaries or subject-facing documents (language compliance).
Checklist of doucments for the application process
Document Set (for the applying country)
- Cover letter (template)
- Part I translations (if required)
- Part II: Recruitment arrangements (danish)
- Part II: Subject information (english)
- Part II: Subject informed consent form (english)
- Part II: Suitability of the investigator: CV and DoI (template)
- Part II: Suitability of the facilities (template)
- Part II: Proof of insurance cover or indemnification
- Part II: Financial and other arrangements (template)
- Part II: Compliance with national requirements on Data Protection (template)