{"count":1608389,"next":"http://info.mzalendo.com/api/v0.1/hansard/entries/?format=json&page=147589","previous":"http://info.mzalendo.com/api/v0.1/hansard/entries/?format=json&page=147587","results":[{"id":1494072,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494072/?format=json","text_counter":509,"type":"speech","speaker_name":"Endebess, UDA","speaker_title":"Hon. (Dr) Robert Pukose","speaker":null,"content":"Registration of 59A. (1) An application for registration of a medical devices medical devices establishment shall be submitted to the Authority in the prescribed establishment. format and shall be accompanied by the prescribed fees. (2) An importer, distributor or dealer will establish a system of notification of field safety corrective action and shall notify the Authority of such system. (3) Where the Authority is satisfied that the application under subsection (1) meets the prescribed requirements, the Director-General shall issue a registration certificate for the medical devices establishment in the prescribed format. (4) A medical devices establishment registration certificate issued under this section shall be valid for a period of one year, renewable annually upon application in accordance with the prescribed conditions. (5) The registration certificate for manufacturers shall be valid for five years following a successful reinspection. (6) The Authority may refuse to issue a medical devices establishment registration certificate where— (a) an applicant has made a false or misleading statement in the application; (b) the Authority has reasonable grounds to believe that issuing the medical devices establishment registration certificate will constitute a risk to the health or safety of patients, users or other persons; or (c) an applicant has failed to meet the prescribed conditions for medical devices establishment registration."},{"id":1494073,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494073/?format=json","text_counter":510,"type":"speech","speaker_name":"Endebess, UDA","speaker_title":"Hon. (Dr) Robert Pukose","speaker":null,"content":"(7) Where the Authority does not issue a medical devices establishment registration certificate under subsection (6), the Authority shall— (a) notify the applicant in writing of the reasons for refusing the registration of the establishment; and (b) cause the applicant to be notified that the applicant may, within a period of three months from the date of notification, furnish the Authority with additional relevant documentation or evidence in support of the application. (8) After the issuance of a medical devices establishment registration certificate, where there is a change to any of the information submitted at the time of application, the holder of the registration certificate shall submit the new information to the Authority within ten working days of the change."},{"id":1494074,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494074/?format=json","text_counter":511,"type":"scene","speaker_name":"","speaker_title":"","speaker":null,"content":"(The new clause was read a First Time)"},{"id":1494075,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494075/?format=json","text_counter":512,"type":"speech","speaker_name":"Hon. Omboko Milemba","speaker_title":"The Temporary Chairman","speaker":{"id":13328,"legal_name":"Jeremiah Omboko Milemba","slug":"jeremiah-omboko-milemba"},"content":" Mover."},{"id":1494076,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494076/?format=json","text_counter":513,"type":"speech","speaker_name":"Endebess, UDA","speaker_title":"Hon. (Dr) Robert Pukose","speaker":null,"content":" Hon. Temporary Chairman, I beg to move that the New Clause 59A be now read a Second Time. This is to make provision for the registration of medical devices establishment."},{"id":1494077,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494077/?format=json","text_counter":514,"type":"speech","speaker_name":"Endebess, UDA","speaker_title":"Hon. (Dr) Robert Pukose","speaker":null,"content":"The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."},{"id":1494078,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494078/?format=json","text_counter":515,"type":"scene","speaker_name":"","speaker_title":"","speaker":null,"content":"(Question, that the new clause be read a Second Time, proposed)"},{"id":1494079,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494079/?format=json","text_counter":516,"type":"scene","speaker_name":"","speaker_title":"","speaker":null,"content":"(Question, that the new clause be read a Second Time, put and agreed to)"},{"id":1494080,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494080/?format=json","text_counter":517,"type":"scene","speaker_name":"","speaker_title":"","speaker":null,"content":"(Question, that the new clause be added to the Bill, put and agreed to) New Clause 59B"},{"id":1494081,"url":"http://info.mzalendo.com/api/v0.1/hansard/entries/1494081/?format=json","text_counter":518,"type":"speech","speaker_name":"Endebess, UDA","speaker_title":"Hon. (Dr) Robert Pukose","speaker":null,"content":"THAT, the Bill be amended by inserting the following new Part immediately after the new Clause 59A— Pharmacovigilance. 59B. (1) The Authority shall establish a National Pharmacovigilance Centre which shall set up and manage the national pharmacovigilance and post marketing surveillance system. (2) The Centre established under subsection (1) shall receive and maintain all relevant information about suspected adverse drug reactions and adverse events to health products or technologies which have been authorized by the Authority. (3) The Authority shall conduct both passive surveillance and active surveillance of health products and technologies. (4) The Authority shall carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements. (5) All entities responsible for placing a health product or technology in the market shall establish and maintain a pharmacovigilance system for managing safety information of health products and technologies. (6) The entities referred to in subsection (5) shall submit safety information to the Authority in the prescribed manner. (7) The consumers, general public and health care professionals shall report adverse reactions and adverse events to the Authority in the prescribed manner."}]}