RESOLUTION – RDC No. 203, OF DECEMBER 26, 2017
Provides for the criteria and procedures for the importation, on an exceptional basis, of products subject to sanitary surveillance without registration at Anvisa.
The Collegiate Board of the National Health Surveillance Agency, in the use of the powers conferred by Article 15, III and IV, alongside Article 7, III, and IV, of Act 9,782, of January 26, 1999, Article 53, V, §§ 1 and 3 of the Internal Regulations approved pursuant to Annex I of the Resolution of the Collegiate Board of Directors – RDC No. 61 of February 3, 2016, resolves to adopt the following Resolution of the Collegiate Board of Directors, as deliberated at the meeting held on December 12, 2017, and I, the Chief Executive Officer, order its publication.
Article 1: This Resolution establishes the criteria and procedures for the importation, on an exceptional basis, of products subject to sanitary surveillance without registration at Anvisa, pursuant to § 5 of Article 8 of Act 9,782, of 1999, and § 5 of Article 7 of Decree 8,077, of 2013, intended exclusively for use in public healthcare programs by the Ministry of Health and its related entities.
Article 2: The provisions of this Resolution cover the products subject to health surveillance to be acquired through international multilateral organizations.
Article 3: The products subject to sanitary surveillance whose drug and/or technology may fall into at least one of the following situations may be authorized for import, on an exceptional basis:
I – Unavailability in the domestic market, as well as lack of duly registered therapeutic alternatives or products used for the same purpose, when they exist;
II – Public health emergency of national importance, pursuant to Decree 7,616 of 2011, or of international importance (ESPII), according to the International Health Regulations;
III – Vaccines that are part of the National Immunization Program, acquired through the Revolving Fund for Immunobiological Acquisitions of the Pan American Health Organization (PAHO) / World Health Organization (WHO); or
IV – Donations from international multilateral organizations or official foreign cooperation agencies.
§ 1. For the purposes of this Resolution, unavailability in the domestic market is characterized as the temporary or permanent incapacity to meet the demand of the Unified Health System by registry holders duly regularized in the country.
§ 2. Acquisitions of products subject to sanitary surveillance to meet the situations of item II of this Article may be authorized even when not carried out through international multilateral organizations.
Article 4: Products to be imported on an exceptional basis shall be prequalified by the World Health Organization (WHO).
§ 1. Where the product type is not subject to WHO prequalification programs, importation may be authorized upon proof of registration valid in a country whose competent regulatory authority is a member of the International Council for Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH) and certification of good manufacturing practice, or an equivalent document in the country.
§ 2. In situations of public health emergency of national or international importance, provided that the impossibility of meeting the requirements established in the heading and § 1 of this Article is justified, importation may be authorized by at least proof of registration valid in the country of origin or where it is marketed.
Article 5 – The Ministry of Health and related entities shall:
I – Request, prior to acquisition of the products referred to in this Resolution, by means of an electronic request and submission of the relevant documentation, the express authorization for the imports, in on an exceptional basis, informing the intended schedule for the importation;
II – Attest, where applicable, the unavailability of the products to be imported, as well as therapeutic alternatives or products used for the same purpose, which are duly regularized in the domestic market;
III – Verify expiration dates and establish mechanisms to guarantee general conditions and maintenance of the quality of products imported, from transportation to receipt and storage;
IV – Provide guidance to health services and patients on the use and preservation of imported products, as well as how to report technical complaints and adverse events related thereto;
V – Create mechanisms for the post-distribution and post-use monitoring of imported products by the health services and so that cases of identified technical complaints and adverse events are reported to Anvisa through the information systems adopted; and
VI – Take responsibility for the collection of imported products, on an exceptional basis, when determined by Anvisa.
Sole paragraph: For products imported pursuant to § 2 of Article 4 of this Resolution, a risk management plan should be prepared for the identification of problems arising from the use of these products and a description of the measures to be adopted.
Article 6: Anvisa shall:
I – Manifest itself within ten (10) business days from the receipt of the request relating to the imports, on an exceptional basis;
II – Monitor the profile of technical complaints and adverse events associated with the use of imported products pursuant to this Resolution; and
III – Publicize the requests for import authorization on an exceptional basis.
Sole paragraph: In cases of public health emergency of national or international importance, the manifestation referred to in item I shall be issued within forty-eight (48) hours from the receipt of the request.
Article 7: At any time, the import authorization, as an exception, may be modified, suspended or waived for technical and scientific reasons or based on information from the control and monitoring of the products covered by this Resolution.
Article 8: Failure to comply with the provisions contained in this Resolution shall constitute a sanitary violation, pursuant to Act 6,437 of August 20, 1977, notwithstanding the applicable civil, administrative and penal liabilities.
Article 9: The provisions of this Resolution do not apply to the acquisition processes initiated or requests for importation on an exceptional basis that were entered into at Anvisa until the beginning of the validity of this standard.
Article 10: This Resolution shall enter into force one hundred and eighty (180) days from the date of its publication.
JARBAS BARBOSA DA SILVA JR.