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Union of India - Section

Section 34 in The Drugs and Cosmetics Rules, 1945

34. Application for license for examination, test or analysis.

(1)An application for a license for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted.
(2)The licensing authority may require such further particulars to be supplied as he may consider necessary.
(3)[ Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.
(4)The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fine."] [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).][34-A. Application for license to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients. [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
(1)An application for an import license for small quantities of a new drug as defined in rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be.
(2)The licensing authority may require such further particulars to be supplied, as he may consider necessary.
(3)Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.
(4)The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fine".]