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"content": "(k) proof that the applicant holds— (i) a valid practising licence issued by the body responsible for the profession of pharmacy; (ii) a valid wholesale dealer’s licence issued in accordance with this Act; (iii)a valid licence to sell poisons issued in accordance with this Act; or (iv) a valid manufacturing licence issued in accordance with this Act; and (v) proof of payment of the application fees as prescribed by the Authority. (4) An applicant shall notify the Authority of any variation to the agreement appointing the local representative within seven days of the variation."
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"content": "(The new clause was read a First Time)"
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"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": " Hon. Temporary Chairman, I beg to move that New Clause 27A be now read a Second Time. In New Clause 27A, a person who intends to import, manufacture or sell a health product or technology shall apply to the Authority for the registration of the health product or health technology in the prescribed form. I move."
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"type": "speech",
"speaker_name": "Hon. Omboko Milemba",
"speaker_title": "The Temporary Chairman",
"speaker": {
"id": 13328,
"legal_name": "Jeremiah Omboko Milemba",
"slug": "jeremiah-omboko-milemba"
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"content": " Hon. Chairman, to ensure that Members understand, you will, in future, be summarising and speaking on them because they are quite a number."
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"id": 1493936,
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"speaker": null,
"content": "(Question, that the new clause be read a Second Time, proposed)"
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"content": "(Question, that the new clause be read a Second Time, put and agreed to)"
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"id": 1493938,
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"content": "(Question, that the new clause be added to the Bill, put and agreed to) New Clause 27B"
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"type": "speech",
"speaker_name": "Hon. Omboko Milemba",
"speaker_title": "The Temporary Chairman",
"speaker": {
"id": 13328,
"legal_name": "Jeremiah Omboko Milemba",
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"content": "THAT, the Bill be amended by inserting the following new clause immediately after Clause 27A– Processing of 27B. (1) The Authority shall consider the application made under application for section 27A, and, shall, if it is satisfied of the safety, efficacy, quality, registration of health product or performance and economic value of the health product or technology, technology. register the health product or technology and issue a certificate of registration in the prescribed form. (2) The Authority may, while considering the application, approve the details as supplied by the applicant or approve it with such amendments as it may consider appropriate in respect of the following particulars— (a) the name under which the health product or technology may be sold; 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."
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"id": 1493940,
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"type": "speech",
"speaker_name": "Hon. Omboko Milemba",
"speaker_title": "The Temporary Chairman",
"speaker": {
"id": 13328,
"legal_name": "Jeremiah Omboko Milemba",
"slug": "jeremiah-omboko-milemba"
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"content": "(b) the labelling of the health product or technology; (c) the statement of the representations to be made for the promotion of the health product or technology regarding— (i) the claim to be made for the health product or technology; (ii) the route of administering the health product or technology; (iii)the dosage of the health product or technology; (iv) the storage conditions of the health product or technology; (v) the contra-indications, the side effects and precautions, if any of the health product or technology; and (vi) the package size of the health product or technology. (3) When evaluating an application, the Authority may— (a) subject a sample of the health product or technology to an evaluation by an analyst; and (b) consider the evaluation report of the analyst that has evaluated the health product or technology. (4) Where the Authority is not satisfied as to the quality, safety efficacy, performance or economic value of the health product or technology, it may, after providing an opportunity to the applicant to be heard, reject the application and inform the applicant the reasons for rejection in writing."
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"content": "(The new clause was read a First Time)"
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