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Regulatory Guidance

The Notice to Applicants is prepared by the European Commission to give the harmonised views how the legal requirements of the Directives and Regulations may be met. The State Agency of Medicines has prepared guidance papers to facilitate the authorisation process and to give the necessary contact points for different questions.

The documentation concerning the marketing authorisations for human and veterinary medicinal products should be submitted electronically only.

State Agency of Medicines encourages the applicants to use CESP (Common European Submission Portal) for submission of marketing authorisation documentation.

We accept all types of submissions for marketing authorisations for human and veterinary medicinal products via CESP: national and MRP/DCP new applications, renewals, variations, response documents, PSURs for veterinary medicinal products, ASMFs etc.

There is no size limit for CESP submissions. If the applicant cannot use CESP the following ways of submissions are accepted:

  • Via email (if < 10 MB) or Eudralink (if < 200 MB per one file) to the e-mail address

[email protected]: applications, responses and additional documentation for marketing authorisation, renewal and variations via national and MRP/DC procedure.

[email protected]: translations of final product information for MRP/DC procedures (initial, renewal, variations)

  • On CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia

Only one way of submission must be used. Sending double submissions leads to confusion and will delay processing of the application.

Centralised Procedure applications for human medicinal products must not be submitted to the State Agency of Medicines. Further guidance can be found here.

PSUR submission

Submitting PSURs for veterinary medicinal products

PSURs for veterinary medicinal products should be submitted via CESP or to the e-mail address [email protected]. For submissions larger than 10MB please use CESP (preferred) or send 1 CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia.

Submitting PSURs for human medicinal products

From 13 June 2016 all PSURs for human medicinal products must be submitted electronically via eSubmission Gateway / Web Client to the PSUR Repository.  Information regarding PSUR Repository is available on the EMA eSubmission website.

  • Requirements for eSubmission

State fees: The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed (State fee).

Samples: The applicant is not required to submit the sample of the medicinal product with the MA application. One sample has to be presented when the medicinal product is actually launched.

Assessment fees: An invoice on the assessment fee will be sent within 10 days after acceptance of the application for processing. The applicant shall pay the fee within 40 days after presentation of the invoice.

For submisson of electronic documentation CESP (Common European Submission Portal) is highly recommended.

The CESP delivery file/e-mail content/labelling of the CD/DVD should include the following information:

  • Name of the applicant/MAH
  • Name of the product
  • Marketing authorisation number
  • For MRP/DCP products the procedure number
  • Submission type (e.g. Marketing Authorisation Application, Variation Type II, Renewal, ASMF)
  • Submission description e.g initial submission, responses etc.
  • Format of the submission
  • eCTD/NeeS sequence number

According to the EU eSubmission Roadmap eCTD format is mandatory for all submissions for human medicinal products from 1 January 2019.

For veterinary medicinal products, the VNeeS format is mandatory for all submissions for veterinary medicinal products from 1 January 2019.

The State Agency performs technical validation of electronic submissions against the current EU technical validation criteria published on the EMA eSubmission website.

The guideline for e-submissions in decentralised and mutual recognition has been published on CMDh and CMDv websites.

Guidance for CESP submissions:

  • Separate CESP submission for each application is required to facilitate the processing of the applications.
  • The same CESP number must never be reused.
  • We advise the applicant to use the comments field of the delivery file to indicate specific information on the submission (e.g. in case of a replacement submission the reason for resubmission must be marked there in order to avoid confusion).
  • Requirements for users of the CESP system on the correct use of Zip files, folder and file names for submissions transferred using the CESP system: Guidance for Zip files, Folder and File Names.

The following documents must be signed by the applicant. Hand-written signatures, digital signatures and mechanical (scanned) signatures are acceptable) for the documents listed below

  • Application for marketing authorisation
  • Application for renewal of marketing authorisation
  • Application for variation to marketing authorisation
  • Letter of access to Active Substance Master File
  • Letter of authorisation for communication on behalf of the applicant/MAH
  • Informed consent letter of marketing authorisation holder of authorised medicinal product for Article 10c ‘informed consent’ applications

The following documents are required with original signature or digital signature (in accordance with the Digital Signatures Act)

  • Withdrawal letter of a marketing authorisation application
  • Withdrawal letter of an application for renewal of marketing authorisation
  • Withdrawal letter of a marketing authorisation

Withdrawal letter of a variation application may be submitted as an e-mail attachment.

SPC, PIL and labelling in Estonian should be presented with the application electronically in Word format in the following cases:  

  • submission of the application for marketing authorisation and renewal applications in national procedure;
  • submission of the application for variation to a marketing authorisation introducing changes to the product information
       - via national procedure: all variations
       - via MRP/DCP: type IA and IB variations

In case the product information in Estonian has not been submitted with the application, it must be sent to [email protected].

For variations and renewals the last approved product information has to be used, all changes in the text should be made only using ‘track changes’ function.

MRP/DCP initial applications and type II variations: Estonian translation of the final approved product information has to be submitted no later than 5 days after the procedure is closed to [email protected].

Product information (SPC, PIL and labelling) in English in Word format must be submitted together with MRP/DCP applications.

Agreed templates have to be used.

The Expert Commission on Pharmaceutical Terminology was established according to Decree No 177 of Minister of Social Affairs dated June 30, 1999. The regular meetings of the Commission have been taken place since September 1999.

The Commission has prepared the translations of standard terms of European Pharmacopoeia.

Translations of the standard terms from english to estonian can be searched using this database.

The marketing authorisation applicants should use the joint terminology in the following cases:

  • Completion of marketing authorisation application forms;
  • Translation of Summary of Product Characteristics and package leaflets into Estonian;
  • On the labelling.

For further information please contact Ott Laius ([email protected])

General requirements

State Agency of Medicines (SAM) reviews, amends (if required) and approves educational materials in case these are part of additional risk minimisation measures (aRMM) set as condition regarding to the safe and effective use of the product. That means materials of

  • Centrally authorised products for which aRMM educational materials are set as a condition in EC decision Annex II D or prepared according to Risk Management Plan which are approved within assessment report.
  • Mutually recognised, decentrally or nationally approved medicinal products for which aRMM educational materials are prepared according to Risk Management Plan which are approved within assessment report.

SAM does not review or approve any educational material which is prepared by the Marketing Authorisation Holder (MAH) on its own initiative. Such materials are considered to be as advertising of medicinal products.

In case MAH on its own initiative considers necessary to apply aRMM (including educational materials to Health Care Professionals (HCP) or patients) to guarantee safe use of the medicinal product, Risk Management Plan must be amended in advance and variation submitted. Only after approval of the variation such materials are considered as part of the marketing authorisation.

Submission of educational materials to SAM

Before distributing aRMM materials to HCPs or patients MAH is requested to submit to SAM English final versions (as PDF files) and Estonian versions as word files (according to article 785 § 9 of Medicinal Products Act). aRMM educational materials must be sent to e-mail [email protected] 

To guarantee fast and smooth process

- On the e-mail Subject line MAH should write “Name of the medicinal product”, “aRMM”, “initial” OR “repeated” (that helps to clarify are Estonian materials sent to SAM for the first time for approval or are they amendments/updated of previously approved materials)

- In the letter MAH should clarify what are the grounds of submission of these materials (condition of marketing authorisation (in Annex II D or in approved RMP)

- In case repeated submission MAH should clarify when materials where approved last time and what are main amendments/changes. All amendments/changes must be done in tracked version.

In addition the following must be submitted:

- Communication plan (to whom materials are meant, distribution plan, in case of repeated materials the clarification how the recall/disposal will be organised) - Estonian speaking contact (according to article 4§ 4 of Regulation of the Ministry of Social Affairs no 26). Other important requirements Educational materials must not contain advertising elements (no product logo or unrelated pictures) Every separate material must have version umber. After approval of educational materials as word (doc) files, MAH must submit final version as pdf file. If required, SAM may propose amendments to the final pdf file. Black triangle – in case the product is in the list of medicinal products under additional monitoring (see, the warning must be included in aRMM materials. Black triangle must be on the cover/first page and explanation in the footer:

 Timelines of review/approval of the aRMM materials

Materials will be reviewed and feedback given to MAH within 2 weeks:

- First-time materials - Previously agreed format or lay-out changes significantly - Significant substantive changes (new warnings)

- Changes in the communication plan - Materials will be reviewed and feedback given to MAH within 5 days:

- Repeated materials (with no significant changes) - Non-significant substantial changes (specification of warnings, revision of mistakes) - Final version as pdf file

Last updated: 17.02.2023