Dossier submission in eCTD format
By the decision of the European Medicines Agency (EMA), the submission of regulatory information on a medicinal product is performed using the electronic Common Technical Document (eCTD), and from 1 January 2020 the submission of dossiers in eCTD format for all submission types in purely national procedures will also become mandatory for the Republic of Croatia.
What is eCTD?
It is a standard for structured electronic submissions aimed to facilitate the submission itself and to increase the trace ability of the life cycle of a specific medicinal product. Its main advantage is the Life Cycle Management (LCM), which is achieved through the use of an XML backbone for navigating through the content and tagging data as well as tracking changes, and represents the master document containing all metadata of an individual submission. The XML instance and .pdf versions of documents form a complete eCTD, which consists of a total of five sections, i.e. five modules:
- Module 1 (administrative data and product information)
- Module 2 (clinical and non-clinical overviews)
- Module 3 (quality)
- Module 4 (non-clinical study reports)
- Module 5 (clinical study reports).
Transition to eCTD format
In view of the obligation set to enter into force in January 2020, there is an emerging need to change the format of previously approved product documentation, which is submitted as a baseline sequence.
The baseline sequence is not mandatory when transitioning to the eCTD format but is desirable because it facilitates the monitoring of a medicinal product’s life cycle and of the regulatory requirements. This also enables the Agency to review previously approved documents more efficiently and easily. It can be sent in two ways: either as part of a new regulatory activity, whereby the baseline sequence and the sequence of the new regulatory activity are attached, or as a baseline sequence together with a written application. Regardless of the method of submission of the baseline sequence, a consolidated version of the previously submitted product documentation is delivered to the Agency, the backbone of which is Module 3 along with other modules that have been updated accordingly.
A complete transition to eCTD submission significantly facilitates the tracking of a medicinal product’s life cycle and any variations that have occurred over time as well as its storage.
Our team has the expertise required for providing successful support and assistance in eCTD compilation: we offer full project management service, including formatting, editing, preparation as well as extensive and knowledgeable communication with competent authorities.
Nika Šperanda, DVM / Regulatory Associate
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)