Proviso: Added vide S.R.O. Pharmacy Services Health Department KP. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG Name(s) of the drug(s): Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case: (i) adequate facilities for first aid; 4.4 Prohibition of unauthorized person (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. 25. 6. Date of filling. Air supply system 1. 17. Medical representative shall not offer inducements to prescribers and dispensers. (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. (3) Name of the drug(s). (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; SECTION--4 (8) Contraceptives. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' 7.2.1 Precautions against dust Toxins. E. Container, packing material, etc. 6. 10.1.10 Starting material re-assay 08.80.040 . Patent number, if any, with date and its date of expiry : (6) Any fee deposited under sub-rule (3)shall in no case be refunded. Each of our licensure programs fulfils different pharmacists' needs. 6.6.1 Storage and disposal (b) major indication(s) for use; (S.R.O. Statement of the Central Research Fund. 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. 14. 4, Date of receipt of sample. Signature of the Analyst. Calculated Paid investment Turnover It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. 1362(I)/96-28.11.96). or the director or manager of the firm or company by which, the drug will be manufactured. 7.1.2 Material handling Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. FORM 6 Potassium Iodine. (5) Filling equipment, Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. 6.2.2 Purchase from producer or established supplier 22. Name of the drug. Patent number, if any, with date and its date of expiry. A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. Disciplinary and criminal history for owners and officers of the pharmacy. Pharmacist-in-charge information, including license number. 3.7.5 Distribution records (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. 28. 7.3.5 Yield deviations (2) The Central Licensing Board shall, before cancelling or suspending a licence under sub-rule (1), provide an opportunity of being heard to the licensee. The more commonly issued license is the "practitioners of the healing . 6, Date of injection, Description of the method of manufacture and quality control with details of the equipment. SECTION -- 8 27. 30. Records of the disposal of rejected batch and batches with-drawn from the market. (ii) licence to manufacture by way of semi-basic manufacture; (d) any substitution of another substance for that drug or any mixing of another substance with that drug; 10. (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; Phenothlazine (B. VET. 10.4.4 Recording batch numbers Reference to Analytical Report number stating whether of standard quality or otherwise. Number and size of containers filed and number rejected. (f) Any other tests. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), (i) Particulars regarding the legal status of the applicant (i.e. Name and address of the manufacturer: Date of Registration Secretary Registration Board (Seal) Chairman. (d) name of manufacturer or distributor. (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; Record maintenance FORM 7 The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. 4.9.2 Practices in personal hygiene 5. 3.5.1 Audit by independent specialist 2.3 Construction Quality control. (f) the applicant shall ensure that-- Proposed shelf life with storage conditions, if any : (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; DISEASES, ADVERTISEMENT FOR TREATMENT OF II. (i) Country. (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. 47. 1. Serial Number, Order cabinetry 7. QUALITY CONTROL DEPARTMENT (iii) Details of the section-wise equipment and machinery for manufacture and quality control. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. (c) toxicity or the side-effects. [See rule 26 (3)] Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. 16. 7.4.10 Discrepancies to be investigated (c) Identification. Magnesium Trisilicate. 15 Type of container : Aseptic Filling and sealing room: The following equipment required :- 9.1 General 3.4.2 Items for self inspection Dose and volume of solution injected into each rabbit and time of injection. 1. The Tableting Section shall be free from dust and floating particles. _________________________ On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. Ammonium Bicarbonate. This exam is to assess the student knowledge, ability to interpret and apply all legislation that impacts on current pharmacy practice in Ontario. (14) Leak tasting equipment. 7.4.4 Process continuity 9. 5,000 4.6 Duties of Production Incharges Fax - (717) 787-7769. Batch number. 3. 9. 8. and There have been/have not been any change in respect of (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- 4.8.1 Written programme Countersigned by .. For Foreign-trained Pharmacy Graduates / Pharmacists. (9) The following information shall be supplied to the Registration Board-- ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. (e) any error in the labelling of that drug; 14. 4.7 Standard Operating Procedures (SOPs) and Records (5) A drug or any substance referred to in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied professions through a documentary film. (i) enclose certificate of registration and Free Sale from any of the following countries: 4.5 Master Formula (2) Moulding equipment. (1) Mixing and pouring equipment. Sterilization by radiation 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; 4.1 General 2.1 The contract giver shall be responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of good manufacturing practices are followed. Filter safety 20. Rs. [See rule (31)1] 12. (iv) Services LICENCE TO MANUFACTURE DRUG(S) 1. (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. (ii) Any other relevant information that may be required by the Board for consideration of this application. 10. 5. (2) Pill machine, where applicable. Proposed dosage : 8. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. Opinion and signature of the approved Analyst 6.5.2 Release 3. SANITATION AND HYGIENE (ii) Details of the premises including layout plan of the factory. (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board. SECTION--3 Pharmacological group _________________________ 9. 2.5 Tanks Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- 113-54 (Drug Supply Chain Security Act). Apply for insurance 11. SCHEDULE C 5 whenever necessary. (2) Capsule filling units. Antigen. (d) Volume in container, 2. ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG (1) Rolling machine. If drains are absolutely necessary they must not contract directly with waterways or public sewers, (iv) licence to manufacture by way of repacking; and 9. FORM 4 (3) Colloid mill or homogeniser. The granulation, tableting and packing shall be done in this room. 10.4.10 Equipment utilization record 3.4 Self inspection (ii) Details of the premises including layout plan of the factory. (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. 13. (k) One physician, to be nominated by the Federal Government; (j) One Surgeon, to be nominated by the Federal Government. Certificate of registration by F.D.A. Employers shall be responsible for the basic and continuing training of their representatives. Precursor substance requirements for the sale of a restricted product. 3.3.6 Production record/batch review (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. Sale at more than one place .- (1) If a person desires to sell, store, exhibit for sa le or distribute drugs at more than one place, he shall apply for a separate license in 5.3 General Requirements for Production Areas (3) Dust proof storage Cabinets. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". Cetrimide Powder. 7. (14) The Licensee shall , by the 30th June and the 31st December each year, Whichever is immediately after the annual financial closing of the company. (e) Testing, (7) The licensee shall comply with the provisions of the Ordinance and the rules and with such further requirements, if any, as may be specified in any rule subsequently made-in this behalf or any other condition that may be imposed at the time of grant of a licence in the special circumstances of each case. (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. Name of the sample. (1) Tablet machine, single punch or rotary. Quality control 3.3.1 General Serial number In order to avoid over-promotion, the main part of the volume of sales they generate. Date of Establishment. (4) Filling equipment. Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence. It is an exam to acquire a license for all medical professionals who would like to work in Dubai. (2) Kettles, steam, gas or electrically heated. 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