Article IX of the drug packaging materials shall be registered by the drug supervision and management department and obtain a "certificate of registration of pharmaceutical packaging materials" before production. Unregistered pharmaceutical packaging materials shall not be produced, sold, operated and used.
"Certificate of Registration of Pharmaceutical Packaging Materials" is valid for five years, six months before the expiration of the prescribed application for reissue.
Article X "certificate of registration of pharmaceutical packaging materials" shall not be forged, altered, rented, loaned.
Article XI of the production of Class I drug packaging materials, shall be approved by the State Drug Administration for registration, and issued "Certificate of Registration of Pharmaceutical Packaging Materials". The production of Ⅱ, Ⅲ type of pharmaceutical packaging materials, by the province, autonomous region, municipality directly under the Central Drug Administration for approval of registration, and issued "Certificate of Registration of Pharmaceutical Packaging Materials".
Article XII of the implementation of the new standards for pharmaceutical packaging materials, pharmaceutical packaging materials manufacturers need to reapply to the original licensing authority for the issuance of "certificate of registration of pharmaceutical packaging materials".
The contents of the certificate of registration of pharmaceutical packaging materials changes, the licensee should be changed within thirty days from the original licensing authority to apply for change procedures or re-registration.
Article XIII of the first imported pharmaceutical packaging materials (foreign enterprises, Sino-foreign joint ventures in overseas enterprises), shall obtain the State Drug Administration issued a "certificate of registration of imported pharmaceutical packaging materials", and by the State Drug Administration authorized the testing of pharmaceutical packaging materials testing organizations qualified before the sale and use in the Chinese People's Republic of China **** and the country.
"Certificate of Registration of Imported Pharmaceutical Packaging Materials" is valid for three years, six months before the expiration of the prescribed application for reissue.
Article XIV of the State Drug Administration registered and issued Type I "Certificate of Registration of Pharmaceutical Packaging Materials" and "Certificate of Registration of Imported Pharmaceutical Packaging Materials", the provinces, autonomous regions, municipalities directly under the Central Drug Administration registration and issuance of Type II, Type III, "Certificate of Registration of Pharmaceutical Packaging Materials" is valid throughout the country.
"Certificate of Registration of Pharmaceutical Packaging Materials" and "Certificate of Registration of Imported Pharmaceutical Packaging Materials" by the State Drug Administration unified printing.
Article XV of the use of imported pharmaceutical packaging materials, with the State Drug Administration issued a copy of the "Certificate of Registration of Imported Pharmaceutical Packaging Materials," stamped with a valid seal of the manufacturer of pharmaceutical packaging materials, by the province, autonomous region, municipality directly under the central government drug supervision and management department for the record before use.
Article XVI of the application for registration of pharmaceutical packaging materials shall have the following basic conditions:
(a) the applicant shall have a business license of the enterprise legal person;
(b) apply for registration of pharmaceutical packaging materials should be in line with China's drug packaging needs and development direction, the state has been ordered to phase out or phase out of the product shall not be registered;
(c) with the production of the product is a reasonable Process, equipment, cleanliness requirements, testing equipment, personnel, management system and other necessary conditions for quality assurance;
(d) the production of Class I pharmaceutical packaging materials products, must also have the same cleanliness conditions with the production of packaged drugs, and by the State Drug Administration or the provinces, autonomous regions and municipalities directly under the central drug supervision and management department designated by the testing organization to check and pass.
Article XVII of the registration of pharmaceutical packaging materials in accordance with the following procedures:
(a) apply for registration of the product shall be sampled in accordance with the provisions of the three batches of the quality of the pharmaceutical packaging materials by the testing organization in line with the statutory standards;
(b) Class Ⅰ of the registration of pharmaceutical packaging materials, applicants to fill in the requirements of the provisions of the "application for registration of materials for pharmaceutical packaging, containers "together with the required information by the provinces, autonomous regions, municipalities directly under the Central Drug Administration, after passing the preliminary examination, reported to the State Drug Administration for approval and issuance of" Certificate of Registration of Pharmaceutical Packaging Materials ";
(C) Ⅱ, Ⅲ type of registration of pharmaceutical packages, applying for enterprises to fill in the requirements of the "application for registration of pharmaceutical packaging materials, containers ", together with the required information to the provinces, autonomous regions and municipalities directly under the Central Drug Administration for approval and issuance of "certificate of registration of pharmaceutical packaging materials", at the same time, the State Drug Administration for the record.
Article 18 of the first domestic development of pharmaceutical packaging materials products shall be approved by the State Drug Administration organization review, according to the category to apply for "Certificate of Registration of Pharmaceutical Packaging Materials".