The main legislative acts regulating the procedure for registration and circulation of medicinal products in Moldova are:
- Law of the Republic of Moldova No. 1456-XII “On pharmaceutical activities” dated May 25, 1993.
- Law of the Republic of Moldova No. 1409-XIII “On medicinal products” dated December 17, 1997.
- Order of the Ministry of Health of the Republic of Moldova No. 739 “On authorization of medicinal products for human use and approval of post-marketing changes” dated May 13, 2012.
Registration of medicinal products is coordinated by the Ministry of Health of the Republic of Moldova; expert evaluation of registration materials is performed by the Agency for medicinal products and medical devices (http://amed.md/).
The Applicant of registration is an entity designated and authorized by the Marketing Authorization Holder (owner) as his representative during the authorization procedure for medicinal products in the Republic of Moldova. The owner of the Registration Certificate of the medicinal product is the inventor, manufacturer or any other legal entity authorized by them, responsible for the effectiveness, quality and safety of the medicinal product. The Applicant of registration can be only a resident of the Republic of Moldova, while the owner of the Registration Certificate can be both a resident and a non-resident.
MAH is responsible for the quality, safety and efficiency of the medicinal product placed on the market and its compliance with the requirements of the Specification.
The medicinal product submitted for primary authorization in the Republic of Moldova must be registered in the country of manufacture, or in the country of the owner of the Registration Certificate, or in one of the countries of the European Economic Area, Switzerland, USA, Canada, Japan, Australia.
New registration
The registration procedure consists of several stages, including primary and specialized expert evaluation. After completion of specialized expert evaluation Commission on medicines forms a positive report, that is entered to the Order of Ministry of Health. After signing the order, the original of the Registration Certificate is issued.
Registration is performed under full or simplified procedure.
Simplified registration procedure
The simplified registration procedure is stipulated by the legislation of Moldova for medicinal products registered in at least one of the countries of the European Economic Area or in Switzerland, USA, Canada, Japan, Australia.
Obvious advantages of the simplified procedure are the shortened expert evaluation period of up to 60 days, exemption to provide samples and standards, exemption from laboratory quality control.
Under the simplified procedure, the submitted dossier should be fully identical to the last (actual) submitted dossier in the reference country.
Full (standard) registration procedure
This procedure applies to all countries except the above.
The duration of specialized expert evaluation is up to 210 days. However, this period does not include the actions that are performed prior to the start of the expert evaluation: obtaining and settling invoices, initial expert evaluation, the time required for the Applicant to prepare responses to observations, the time required to conduct the inspection of the manufacturing site (if necessary), drafting and signing the Order, inclusion of the medicinal product into the register, issuing the original certificate.
The Applicant has the right to suspend the authorization process for up to 5 years.
The registration dossier is submitted in the CTD format:
- Module 1 is submitted in paper format. Part of the administrative documentation must be legalized. Eudra certificates are allowed to be submitted without notarization.
- Modules 2-5 are submitted on an electronic media.
The documentation is submitted in Romanian, or in English, or in Russian.
The SmPC is submitted in translation into Romanian language.
A draft of the annotation-insert is submitted in accordance with the national form in Romanian.
The package labeling is also submitted in Romanian. Additional languages are allowed provided the information is identical with the Romanian text.
For medicinal products intended for use by medical personnel, for example: hospital supplies (anesthetics, infusion solutions, vaccines, radiopharmaceuticals, blood derivatives or blood serums), or “orphan drugs”, or drugs used for substitution therapy, the primary and secondary packaging is allowed in the international language/languages.
In-registration laboratory quality control is not performed:
- for medicinal products registered by the EMA, or produced in one of the countries of the European Economic Area, or in Switzerland, USA, Canada, Japan, Australia;
- for medicinal products, the manufacturing site of which was inspected by one of the participating countries/a member of PIC/S, is confirmed by the GMP certificate issued by the authorized body of that country.
Registration certificate
The validity period of the Registration Certificate is 5 years. The medicinal product placed on the market within the validity of the certificate is allowed for use in medical practice until the expiration date.
The Registration Certificate may be revoked by the Ministry of Health in the event that the medicinal product has not been supplied to the country within three (3) years from the date of issue of the Registration certificate.
Variations and changes
The Holder of the Registration certificate within the period of its validity is obliged to notify and receive permission from the Agency for medicinal products and medical devices regarding any changes.
The types of changes in Moldova are close to those of the EU:
- Urgent safety restriction;
- Change in the content (terminology);
- Type IA changes;
- Type IB changes;
- Type II changes;
- Transfer of the Registration certificate (MAH transfer);
- Extension of the product line (changes that lead to the issue of the new Registration certificate).
Each change is submitted by a separate Application, except for successive changes (the change that is the inevitable result of another change).
The approved changes must be enforced within a period of no more than 6 months from the date of their approval. The Holder of the Registration certificate is required to inform the Agency for medicinal products and medical devices on the date of introduction of batches into circulation in accordance with the newly approved post-registration changes.
Renewal of registration
Application for renewal of registration should be submitted to the Agency for medicinal products and medical devices not earlier than 6 months before expiry of the registration certificate.
The list of documentation required for renewal of registration is reduced in comparison with new registration. During re-registration, the Applicant must confirm the absence of changes, or submit them for approval.
The laboratory quality control of the samples may be required during renewal. Such control is not performed if proved that there are no changes in the specification for the finished medicinal product, and there has been no rejection of import during the last 5 years.
The registration certificate is issued for 5 years, then renewal is required.
Cratia provides professional services of state registration (renewals, variations) of medicinal products in Moldova. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.