11.03.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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10.03.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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09.03.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
ERRATA to the notification of 06.03.2026
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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06.03.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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24.02.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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02.02.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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23.01.2026
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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24.12.2025
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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24.12.2025
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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24.12.2025
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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18.12.2025
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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16.12.2025
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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15.12.2025
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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30.12.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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10.12.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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26.11.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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17.11.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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08.11.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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04.11.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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20.10.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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13.10.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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05.10.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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21.09.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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13.09.2021
To the attention of all wholesale distributors of medicinal products for special needs
Considering the provisions of Art. 15 points d) and f) of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, approved through Order of the Minister of Health no. 85/2013, as further amended and supplemented, according to which:
”Art. 15 – The wholesale distributor of medicinal products for special needs has the following obligations: (…)
d) to notify the National Agency for Medicines and Medical Devices of Romania on the actual imported/marketed quantity of the respective medicinal product for special needs at each supply/release as well as about any other issue related to its supply, until the 15th of each month, as well as at any time of a working day, upon request of the National Agency for Medicines and Medical Devices of Romania, throughout the authorisation’s validity period; (…);
f) to provide adequate and continuous stocks throughout the validity of the authorisation regarding the provision of medicinal products for special needs, so that there are no discontinuations in the supply of the market, respectively to ensure at least the average monthly quantity for which the authorisation was issued. “,
All wholesale distributors of medicinal products for special needs are obliged to comply with the above-mentioned legal provisions and notify the NAMMDR, using the Form attached to this notification.
We also inform you that the transmission of this data shall be done via the following e-mail addresses:
ans@anm.ro
secretariat@anm.ro
presedinte@anm.ro
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09.09.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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26.08.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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16.08.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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02.08.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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23.07.2021
To the attention of all wholesale distributors of medicinal products, authorised in Romania
According to Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, as further amended and supplemented and given the request of specialised commissions of the Ministry of Health to place on the market medicinal products which cannot be temporarily insured, through ordinary distribution channels and/or which do not have a valid marketing authorisation in Romania, the Ministry of Health hereby communicates the list of medicinal products included in the category of “special needs”.
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