Single digital gateway for public services
National Agency for Medicines and Medical Devices of Romania*
Available procedures
PROCEDURA
Companii
National
Procedure regarding the approval of activities in the field of medical devices carried out by authorized legal or natural persons, for which the applicant's competence and capability to carry out the respective activities are evaluated by issuing a renewed approval.*
The purpose of this procedure is to transmit and process the request for the issuance of a renewed operating permit for activities in the field of medical devices. The renewed operating permit is issued at the request of the economic operator, when the applicant holds an operating permit for activities in the field of medical devices, within the renewal period, valid. The request shall be accompanied by the OPIS for evaluating the import/distribution activity of medical devices and/or OPIS for evaluating the installation and/or maintenance activity of medical devices, completed using diacritics in the economic operator's section, as well as all documents required in the OPIS specific to the activity, in the order of the OPIS. All the necessary information for the process of issuing a renewed operating permit, as well as the forms for the requested documents, can be downloaded from the website of the National Agency for Medicines and Medical Devices of Romania at www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is conditional on payment of the corresponding fee.
The authorization of activities in the field of medical devices carried out by legal entities or authorized individuals is materialized by the issuance by the Authorization Department within the General Directorate for Medical Devices of the National Agency for Medicines and Medical Devices of Romania of a renewed operating permit in the field of medical devices, which constitutes a document with the legal value of an administrative act with individual character, in favor of its holder. The renewed operating permit will be accompanied by the evaluation report which constituted the basis for issuing the renewed permit.
Renewed operating permits issued in accordance with these current methodological norms are valid for a period of 3 years from the date of issue, if the conditions that formed the basis for authorization remain unchanged. The request for renewal of the operating permit must be submitted to ANMDMR at least 6 months before its validity expires. Otherwise, the authorization procedure will be resumed.
The General Directorate for Medical Devices of the National Agency for Medicines and Medical Devices of Romania is the national competent authority in the field of medical devices.
*
PROCEDURA
Companii
National
Procedure regarding the approval of activities in the field of medical devices carried out by authorized legal or natural persons, for which the competence and capability of the applicant to carry out the respective activities are assessed by issuing an approval*
The purpose of this procedure is the submission and processing of the application for the issuance of an operating permit for activities in the field of medical devices. The operating permit is issued at the request of the economic operator, when the applicant does not hold a valid operating permit for activities in the field of medical devices. The application shall be accompanied by the Table of Contents for the evaluation documentation for activities of import/distribution of medical devices and/or Table of Contents for the evaluation documentation for activities of installation and/or maintenance of medical devices, completed using diacritics in the economic operator’s section, as well as all documents requested in the table of contents, in the order specified therein. All information necessary for the issuance of an operating permit, as well as the forms for the requested documents, can be downloaded from the website of the National Agency for Medicines and Medical Devices of Romania www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is conditional on the payment of the related fee.
The authorization of activities in the field of medical devices carried out by legal persons or authorized natural persons is materialized by the issuance by the Authorization Department within the General Department for Medical Devices of the National Agency for Medicines and Medical Devices of Romania of an operating permit in the field of medical devices, which represents a document with the legal value of an administrative act with individual character, in favor of its holder. The operating permit will be accompanied by the evaluation report that formed the basis for the issuance of the permit.
Operating permits issued in accordance with these applicable methodological norms are valid for a period of 3 years from the date of issuance, if the conditions that formed the basis for the authorization remain unchanged. The application for renewal of the operating permit must be submitted to the NAMMD at least 6 months before its expiration. Otherwise, the authorization procedure will be resumed.
The General Department for Medical Devices of the National Agency for Medicines and Medical Devices of Romania is the national competent authority in the field of medical devices.
*
PROCEDURA
Companii
National
Procedure regarding the approval of activities in the field of medical devices carried out by authorized legal or natural persons who hold a valid operating approval and who wish to modify it by issuing an annex to the held operating approval*
The purpose of this procedure is the submission and processing of the request for amending the operating authorization held by the economic operator for activities in the field of medical devices. The annex to the held operating authorization is issued at the request of the economic operator, when the applicant holds an operating authorization for activities in the field of medical devices, valid, and wishes to amend it by expanding or restricting the field of activity. The request will be accompanied by the LIST of documents for evaluation of import/distribution activity of medical devices and/or the LIST of documents for evaluation of installation and/or maintenance activity of medical devices, completed using diacritics in the economic operator's section, as well as all documents requested in the LIST specific to the activity, in the order of the LIST, in case the extension of the field of activity is requested by adding a work point with activity in the field of medical devices or by adding activity to an address already in the held authorization. If the change of the registered office address is requested, an office where activities in the field of medical devices are carried out, it will be treated as the addition of a work point. For all other amendments provided in the request for amending the operating authorization (Annex 2 to the current methodological norms in force), the documents provided in the application shall be attached as well as all documents requested by the inspector responsible for the file. All necessary information for the process of issuing an annex to the held operating authorization, as well as forms for the requested documents, can be downloaded from the website of the National Agency for Medicines and Medical Devices of Romania at www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. File evaluation is conditioned by payment of the corresponding fee.
The authorization of new activities or new locations where activities are carried out in the field of medical devices by legal entities or authorized natural persons is materialized by the issuance by the Authorization Directorate within the General Directorate of Medical Devices of the National Agency for Medicines and Medical Devices of Romania of an annex to the operating authorization held in the field of medical devices, which represents a document with legal value as an administrative act of individual character, in favor of its holder. The annex to the operating authorization is valid only accompanied by the initial authorization, for the duration of the validity of the authorization. The annex to the operating authorization will be accompanied by the Evaluation Report which formed the basis for issuing the annex only if one or more work points with activity in the field of medical devices are added, or if one or more activities are added to one or more addresses already in the held authorization.
The General Directorate of Medical Devices of the National Agency for Medicines and Medical Devices of Romania is the national competent authority in the field of medical devices.
*
PROCEDURA
Companii
National
Cross-border
Direct communication to healthcare professionals (DHPC)*
The purpose of this procedure is the transmission of a direct communication to healthcare professionals by a marketing authorization holder for the concerned medicine(s), either at the request of the ANMDMR or another competent authority in the EU or the European Medicines Agency, or at the initiative of the marketing authorization holder. Before distributing the communication to healthcare professionals, the marketing authorization holder requests the approval of the ANMDMR regarding the content of the DHPC and the communication plan.
*
PROCEDURA
Companii
National
Cross-border
Notifications from Marketing Authorization Holders regarding discontinuation*
The purpose of this procedure is to inform ANMDMR regarding medicine shortages, received from the Marketing Authorization Holders by completing the form attached to it.
*
PROCEDURA
Companii
National
Notification of intra-community deliveries of medicines for human use by authorized wholesale distributors*
The purpose of this procedure is the notification of ANMDMR regarding the execution of an intra-community delivery, including transactions between two or more branches of the same company located in different countries, according to the provisions of the Order of the Minister of Health no. 269/2017.
The ultimate purpose of the notification is to ensure compliance with the public service obligation, namely the obligation to ensure adequate and continuous stocks of medicines.
The notification is drawn up according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with the information from the List of medicines for human usehttps://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: trade name of the medicine, INN, pharmaceutical form, concentration, package size, CIM code, ATC code, MAH name) and is sent together with the centralizing table regarding the notified medicines, drawn up in .xls format, on the PCUe platform.
*The ultimate purpose of the notification is to ensure compliance with the public service obligation, namely the obligation to ensure adequate and continuous stocks of medicines.
The notification is drawn up according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with the information from the List of medicines for human usehttps://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: trade name of the medicine, INN, pharmaceutical form, concentration, package size, CIM code, ATC code, MAH name) and is sent together with the centralizing table regarding the notified medicines, drawn up in .xls format, on the PCUe platform.
PROCEDURA
Companii
National
Request for scheduling the inspection for the authorization / recertification of good wholesale distribution practice of medicinal products for human use*
The purpose of this procedure is to request the scheduling of an inspection for the authorization/recertification of good practice for wholesale distribution of medicinal products for human use, by a wholesale distributor of medicinal products for human use, according to the provisions of the Order of the Minister of Health no. 131/2016, with subsequent amendments and additions.
The request for inspection scheduling is prepared according to the model provided in Annex no. 1 of the Order of the Minister of Health no. 131/2016 and uploaded to the PCUe platform.
The application form for the Wholesale Distribution Authorization for medicinal products for human use is prepared according to the model provided in Annex no. 2 of the Order of the Minister of Health no. 131/2016 and is sent, together with the administrative and technical documents specified in Art. 4 (5) of the Order of the Minister of Health no. 131/2016, directly to ANMDMR, electronically using the ANMDMR upload platform at https://www.anm.ro/upload/ or by email to registratura@anm.ro or in printed format using courier services, to the address Str. Av. Sănătescu no. 48, sector 1, 011478 Bucharest.
PROCEDURA
Companii
National
Notification of intra-community deliveries of human medicinal products included in the Treatment Protocol for SARS-CoV-2 virus infection, as well as of high-risk medicines for discontinuity intended for chronic diseases in the context of the pandemic*
The purpose of this procedure is to notify ANMDMR regarding the execution of an intra-community delivery outside the territory of Romania under certain conditions, according to the provisions of the Order of the Minister of Health no. 672/2020.
The final purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to ensure adequate and continuous stocks of medicines, through temporary restrictive measures regarding their distribution outside the territory of Romania, justified by public health protection and proportional to the objectives of this protection.
The notification is completed according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with information from the Nomenclature of human use medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (referring to: medicinal product trade name, INN, pharmaceutical form, strength, pack size, CIM Code, ATC Code, MAH name) and is submitted, together with the centralizing table regarding the notified medicines, completed in .xls format, in the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to ANMDMR, the rejection decision if they consider the decision to be unfounded, presenting the necessary arguments in this regard. The contestation is submitted in the PCUe platform.
*The final purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to ensure adequate and continuous stocks of medicines, through temporary restrictive measures regarding their distribution outside the territory of Romania, justified by public health protection and proportional to the objectives of this protection.
The notification is completed according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with information from the Nomenclature of human use medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (referring to: medicinal product trade name, INN, pharmaceutical form, strength, pack size, CIM Code, ATC Code, MAH name) and is submitted, together with the centralizing table regarding the notified medicines, completed in .xls format, in the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to ANMDMR, the rejection decision if they consider the decision to be unfounded, presenting the necessary arguments in this regard. The contestation is submitted in the PCUe platform.
PROCEDURA
Companii
National
Monthly reporting of the placing on the Romanian market and the sales of medicinal products for human use by authorized wholesalers/importers/manufacturers*
The purpose of this procedure is the submission by authorized manufacturers, importers, and wholesale distributors of monthly reports regarding all commercial operations, including parallel imports, and the distribution of medicines outside the territory of Romania to other states in the European Economic Area, carried out with human-use medicines from their own portfolio, in accordance with the provisions of Order of the Minister of Health no. 502/2013.
The ultimate aim of the reporting is to ensure the traceability of medicines throughout the entire chain, from manufacturing and/or distribution to community pharmacy, hospital pharmacy, or drugstore level, to verify the correctness of dispensing medicines with or without medical prescription, to detect falsified medicines and prevent their entry into the authorized distribution network, to combat the existence of illegal parallel sales circuits of medicines, and to guarantee the rapid withdrawal of non-compliant medicine batches or in cases of health emergencies.
Reporting is prepared according to the Guide regarding the completion of the table for monthly electronic reporting of distributed medicines by wholesale distributors/importers/manufacturers as provided in the Annex to Order of the Minister of Health no. 502/2013 and is submitted, together with the legal representative's own responsibility declaration on the conformity of the reported data, in the PCUe platform.
*The ultimate aim of the reporting is to ensure the traceability of medicines throughout the entire chain, from manufacturing and/or distribution to community pharmacy, hospital pharmacy, or drugstore level, to verify the correctness of dispensing medicines with or without medical prescription, to detect falsified medicines and prevent their entry into the authorized distribution network, to combat the existence of illegal parallel sales circuits of medicines, and to guarantee the rapid withdrawal of non-compliant medicine batches or in cases of health emergencies.
Reporting is prepared according to the Guide regarding the completion of the table for monthly electronic reporting of distributed medicines by wholesale distributors/importers/manufacturers as provided in the Annex to Order of the Minister of Health no. 502/2013 and is submitted, together with the legal representative's own responsibility declaration on the conformity of the reported data, in the PCUe platform.
PROCEDURA
Companii
National
Cross-border
Payment forms for the settlement of the fee and charge for applications for authorization/renewal of marketing authorization for medicines*
The purpose of this procedure is the submission and processing of payment forms for the payment of the fee and charge for marketing authorization/renewal requests of medicinal products.
Useful links:
https://www.anm.ro/medicamente-de-uz-uman/legislatie/legi-ordonante-si-hotarari-de-guvern/
PROCEDURA
Companii
National
Procedure regarding the approval of activities in the field of medical devices carried out by authorized legal or natural persons, for which the applicant’s competence and capability to carry out the respective activities are evaluated by issuing a temporary approval*
The purpose of this procedure is the transmission and processing of the request for issuing a temporary operating permit for activities in the field of medical devices. The temporary operating permit is issued at the request of the economic operator, when the applicant does not hold an operating permit for activities in the field of medical devices, valid. The request will be accompanied by the OPIS - List of documents required for temporary authorization of import/distribution/storage activity of medical devices, filled in with the use of diacritics in the economic operator's section, as well as all documents requested in the specific list for the temporary permit, in the order of the list. All information required in the process of issuing a temporary operating permit, as well as the forms for the required documents, can be downloaded from the website of the National Agency for Medicines and Medical Devices of Romania at www.anm.ro under the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is conditioned by the payment of the corresponding fee.
The authorization of activities in the field of medical devices carried out by legal persons or authorized natural persons is materialized by issuing, by the Authorization Directorate within the General Directorate of Medical Devices of the National Agency for Medicines and Medical Devices of Romania, a temporary operating permit in the field of medical devices, which represents a document with legal value of an administrative act with individual character, in favor of its holder. The operating permit will be accompanied by the Evaluation Report which was the basis for issuing the temporary permit.
In the event of the establishment of a state of emergency on the territory of Romania by decree of the President of Romania, to ensure the availability of absolutely necessary medical devices in that situation, ANMDMR will issue a temporary operating permit. The validity period of the temporary permit is 6 months. Temporary operating permits are identified by the initial T preceding the permit number. The temporary operating permit will be issued within a maximum of 7 days from the submission of all required documents and confirmation of payment of the fiscal invoice.
The General Directorate of Medical Devices of the National Agency for Medicines and Medical Devices of Romania is the national competent authority in the field of medical devices.
*
National Agency for Medicines and Medical Devices of Romania*
Str. Aviator Sănătescu 48
Telefon:
+40213171100
Fax:
+40213163497
Email:
secretariat@anm.ro
Assistance services
There are no Assistance services registered by this institution
Institutional structure
Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România
Direcţia Farmacovigilenţă şi Managementul Riscului
Direcţia Avizare
Direcția Generală Inspecție Farmaceutică
Serviciul Registratură și Arhivă
Direcția Avizare