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The 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 competence and capability of the applicant to carry out the respective activities are evaluated by issuing a renewed approval*
The purpose of this procedure is the submission and processing of the request for issuing a renewed operating authorization for activities in the field of medical devices. The renewed 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, within the renewal period, valid. The request will be accompanied by the INDEX of documents evaluating the activity of import/distribution of medical devices and/or the INDEX of documents evaluating the activity of installation and/or maintenance of medical devices, filled in using diacritics in the section for the economic operator, as well as all documents requested in the index specific to the activity, in the order of the index. All necessary information in the process of issuing a renewed 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 www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is conditioned upon payment of the corresponding fee.
The authorization of activities in the field of medical devices carried out by legal entities or authorized natural persons is materialized by the issuance by the Authorization Department within the General Department of Medical Devices of the National Agency for Medicines and Medical Devices of Romania of a renewed operating authorization. in the field of medical devices representing a document with legal value as an administrative individual act, in favor of its holder. The renewed operating authorization will be accompanied by the Evaluation Report that formed the basis for the issuance of the renewed authorization.
The renewed operating authorizations issued in accordance with these current methodological norms are valid for a period of 3 years from the date of issuance, if the conditions that formed the basis of the authorization remain unchanged. The request for renewal of the operating authorization must be submitted to ANMDMR at least 6 months before its expiry date. Otherwise, the authorization procedure will restart.
The General Department 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.
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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 an approval*
The purpose of this procedure is the transmission 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 an operating permit for activities in the field of medical devices, valid. The request will be accompanied by the INDEX of the documentation for the evaluation of import/distribution activity for medical devices and/or the INDEX of the documentation for the evaluation of the activity 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 index specific to the activity, in the order of the index. All the information necessary for the process of issuing 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 at www.anm.ro at 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 entities or authorized natural persons materializes by issuing, by the Authorization Directorate within the General Directorate for Medical Devices of the National Agency for Medicines and Medical Devices of Romania, an operating permit in the field of medical devices, which represents a document with the legal value of an administrative act with an 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 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 application for renewal of the operating permit must be submitted to the 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.
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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 permit and who wish to modify it by issuing an annex to the held operating permit*
The purpose of this procedure is the submission and processing of the application for the modification of the operation permit held by the economic operator for activities in the field of medical devices. The annex to the operation permit held is issued at the request of the economic operator, when the applicant holds a valid operation permit for activities in the field of medical devices and wishes to modify it by extending or restricting the scope of activity. The request will be accompanied by the INDEX of documents for activity evaluation for import/distribution of medical devices and/or the INDEX of documents for activity evaluation for installation and/or maintenance of medical devices, completed using diacritics in the economic operator’s section, as well as all the documents requested in the index specific to the activity, in the order of the index, in case the extension of the scope of activity is requested by adding a work location with activity in the field of medical devices or by weathering an activity at an address already existing in the held permit. 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 location. For all other modifications provided for in the request for modification of the operation permit (annex 2 to these current methodological norms), the documents provided for in the request as well as all documents requested by the inspector responsible for the file must be attached. All information necessary in the process of issuing an annex to the held operation 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 assessment of the file is subject to payment of the related fee.
Approval of new activities or new locations where activities in the field of medical devices are performed by legal or authorized natural persons is materialized by issuing, by the Approval Directorate within the General Directorate for Medical Devices of the National Agency for Medicines and Medical Devices of Romania, an annex to the operation permit held in the field of medical devices, which represents a written document with the legal value of an individual administrative act, in favor of its holder. The annex to the operation permit is valid only with the initial permit, for the duration of the permit's validity. The annex to the operation permit will be accompanied by the Evaluation Report which formed the basis for issuing the annex only in the case where one or more work locations with activity in the field of medical devices are added or one or more activities are added at one or more addresses already existing in the held permit.
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.
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PROCEDURA
Companii
National
Cross-border
Direct communication to healthcare professionals (DHCP)*
The purpose of this procedure is to transmit a Direct Healthcare Professional Communication by a marketing authorization holder for the concerned medicinal product(s), either at the request of ANMDMR or another competent authority from 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 ANMDMR regarding the content of the DHPC and the communication plan.
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PROCEDURA
Companii
National
Cross-border
Notifications from Marketing Authorization Holders regarding discontinuation*
The purpose of this procedure is to inform ANMDMR regarding the discontinuities of medicines, received from the Marketing Authorization Holders through the completion of the form attached to this procedure.
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PROCEDURA
Companii
National
Notification of intracommunity deliveries of human-use medicines by authorized wholesale distributors*
The purpose of this procedure is to notify 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 final purpose of the notification is to ensure compliance with the public service obligation, namely the obligation to provide 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 Nomenclature of Human Medicineshttps://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: medicine trade name, INN, pharmaceutical form, strength, packaging size, CIM code, ATC code, MAH name) and is submitted, together with the centralizing table regarding the notified medicines, drafted in .xls format, on the PCUe platform.
*The final purpose of the notification is to ensure compliance with the public service obligation, namely the obligation to provide 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 Nomenclature of Human Medicineshttps://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: medicine trade name, INN, pharmaceutical form, strength, packaging size, CIM code, ATC code, MAH name) and is submitted, together with the centralizing table regarding the notified medicines, drafted in .xls format, on the PCUe platform.
PROCEDURA
Companii
National
Request for scheduling the inspection for the authorization / recertification of good practice in wholesale distribution of medicines for human use*
The purpose of this procedure is to request the inspection scheduling for the authorization / recertification of good wholesale distribution practice of medicines for human use, by a wholesale distributor of medicines 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 scheduling the inspection is prepared according to the model provided in Annex no. 1 to the Order of the Minister of Health no. 131/2016 and uploaded to the PCUe platform.
The application form for the Authorization for wholesale distribution of medicines for human use is prepared according to the model provided in Annex no. 2 to the Order of the Minister of Health no. 131/2016 and sent, together with the administrative and technical documents provided in Art. 4 (5) of the Order of the Minister of Health no. 131/2016, directly to ANMDMR, in electronic format, 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 medicinal products for human use included in the Treatment Protocol for SARS-Cov-2 virus infection, as well as medicinal products with a high risk of discontinuation intended for chronic pathologies in the context of the pandemic*
The purpose of this procedure is the notification of ANMDMR regarding the performance of an intra-community delivery outside the Romanian territory under certain conditions, according to the provisions of the Order of the Minister of Health no. 672/2020.
The ultimate purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to provide adequate and continuous stocks of medicines, through temporary restrictive measures concerning their distribution outside the Romanian territory, justified by the protection of public health and proportional to the objectives of this protection.
The notification is prepared in accordance with the Annex to the Order of the Minister of Health no. 269/2017, for each medicinal product, with the information from the Nomenclature of Human Medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, pack size, CIM code, ATC code, MAH name) and is sent, together with the centralizing table regarding the notified medicines, prepared in .xls format, via the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to the ANMDMR, the rejection decision in case it considers the decision is unfounded, presenting the necessary arguments in this respect. The contestation is sent on the PCUe platform.
*The ultimate purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to provide adequate and continuous stocks of medicines, through temporary restrictive measures concerning their distribution outside the Romanian territory, justified by the protection of public health and proportional to the objectives of this protection.
The notification is prepared in accordance with the Annex to the Order of the Minister of Health no. 269/2017, for each medicinal product, with the information from the Nomenclature of Human Medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, pack size, CIM code, ATC code, MAH name) and is sent, together with the centralizing table regarding the notified medicines, prepared in .xls format, via the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to the ANMDMR, the rejection decision in case it considers the decision is unfounded, presenting the necessary arguments in this respect. The contestation is sent on the PCUe platform.
PROCEDURA
Companii
National
The monthly reporting of placing on the Romanian market, respectively of sales of medicinal products for human use by authorized wholesale distributors/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 import, as well as the distribution of medicines outside the territory of Romania, to other states in the European Economic Area, carried out with human medicinal products from their own portfolio, according to the provisions of the Minister of Health Order no. 502/2013.
The final purpose of the reporting is to ensure the traceability of medicines throughout the entire chain, from manufacturing and/or distribution up to the level of community pharmacy, hospital pharmacy, and drugstore, to verify the correctness of releasing medicines with or without medical prescription, to detect falsified medicines and to prevent their entry into the authorized distribution network, to combat the existence of illegal parallel circuits for the sale of medicines, and to guarantee the rapid withdrawal of non-compliant batches of medicines or in cases of health emergencies.
The reporting is prepared in accordance with the Guide on completing the table for the monthly electronic reporting of medicines distributed by wholesale distributors/importers/manufacturers provided in the Annex to the Minister of Health Order no. 502/2013 and is submitted, together with the statement on own responsibility of the legal representative of the company performing the reporting regarding the compliance of the transmitted data, on the PCUe platform.
*The final purpose of the reporting is to ensure the traceability of medicines throughout the entire chain, from manufacturing and/or distribution up to the level of community pharmacy, hospital pharmacy, and drugstore, to verify the correctness of releasing medicines with or without medical prescription, to detect falsified medicines and to prevent their entry into the authorized distribution network, to combat the existence of illegal parallel circuits for the sale of medicines, and to guarantee the rapid withdrawal of non-compliant batches of medicines or in cases of health emergencies.
The reporting is prepared in accordance with the Guide on completing the table for the monthly electronic reporting of medicines distributed by wholesale distributors/importers/manufacturers provided in the Annex to the Minister of Health Order no. 502/2013 and is submitted, together with the statement on own responsibility of the legal representative of the company performing the reporting regarding the compliance of the transmitted data, on the PCUe platform.
PROCEDURA
Companii
National
Cross-border
Payment forms for the payment of the fee and tariff for applications for authorization/renewal of the marketing authorization of medicines*
The purpose of this procedure is the submission and processing of payment forms for the payment of the fee and the tariff for applications for authorization/renewal of the marketing authorization of medicines.
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 competence and capability of the applicant to carry out the respective activities is evaluated by issuing a temporary approval.*
The purpose of this procedure is the submission and processing of the request for the issuance of 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 have a valid operating permit for activities in the field of medical devices, valid. The request will be accompanied by the OPIS Required documents for temporary authorization of activity for import/distribution/storage of medical devices, filled in using diacritics in the economic operator's section, as well as all documents requested in the specific opis for the temporary permit, in the order of the opis. All the information required in the process of issuing a temporary operating permit, 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 www.anm.ro at 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 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 a temporary operating permit in the field of medical devices, which represents a document with legal value as an individual administrative act, 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, the 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 which precedes the permit number. The temporary operating permit will be issued within a maximum of 7 days from the submission of all requested documents and confirmation of the payment of the tax 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.
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The 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