(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. Vaccines. open lesions or skin infection shall be engaged in production areas. Toxins. Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. 6, Date of injection, (1) Mixing and blending equipment. Opinion and signature of the approved Analyst Analytical report number. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; Calamine. (8) Hot Air Steriliser, A total area of not less than 900 square feet for the three Sections is required for basic installations. 3. (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. 3.2 Services Maintenance of equipment 2 Examinations. (B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :-- 3. Undertaking to manufacture drug locally within two years. STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE Dose and volume of solution injected into each rabbit and time of injection. (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. 10. 6.9.2 Use FORM 1-A A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. 6. Name of the drug: 3.6.1 Review of complaints (a) For the grant of licence: Type of licence Fee (All weighings and measurements shall be checked initiated b the competent person in the section). (f) Pyrogen test, wherever applicable. Pharmacist-in-charge information, including license number. 31. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. Signature of the examiner. (vii) Packaging SECTION-I Information on price to the consumer shall be accurately and honestly portrayed. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- (All weighings and measurements shall be checked and initialled by the competent person in the section). 10.1.10 Starting material re-assay Summed response, General Contract Giver 3.3 Control procedures (11) Subject to rule 14, the Central Licensing Board may appoint a licensing authority or authorities for such purpose as it may deem fit. Order cabinetry 7. 4. 6 wherever necessary. 6.1.2 Appropriate storage (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. (a) Generic international non-proprietory name: 4. (6) No advertisement under this rule shall contain any direct or indirect comparison in any way with any other drug or substance or remedy for any disease for the purpose of attracting customers or with a view to discredit other such product. Methylene Blue. (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. In Pakistan a person who has following qualification will be considered as an eligible candidate for course of pharmacy technician; Matriculation with science from a recognized institute of Pakistan. 14. ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. The system includes the following modules: Pharma Council Module: Designed for Pharma Council to verify qualified person/pharmacist (s) credentials. [See rule 5 (/)] Quality control. (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. 4. Personnel training 29. (ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity: (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- Ammonium Chloride. 3.7.5 Distribution records The following basic hygienic requirement shall be complied with (6) Antacid and carminatives: (ah) "pharmaceutical product" means any drug intended for human use or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form; 5.1 General responsibility of licensee 3. Type of licence Fee and Denmark. (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. 6.7.2 Returned goods Care of starting materials Test Report number. (4) Compressing machine. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976); 2.1 General 3.6.5 Investigations 18. Gripe Waters. (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; (z) "manufacturer" means a company that carries out at least one step of manufacture; Care against fibers (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. It is an exam to acquire a license for all medical professionals who would like to work in Dubai. 5. Medical representative shall not offer inducements to prescribers and dispensers. 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. Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). An area of minimum of 300 square feet is required for the basic installations. (6) Any fee deposited under sub-rule (3)shall in no case be refunded. Pay your fees using internationally accredited credit cards e.g. Venereal diseases. 5. [See rule 26 (3)] (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; (ii) Reasons thereof. 11. Year (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- Countersigned by .. (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. (5) Various liquid measures and weighing scale. Application fee $10.00: Pay by credit or debit card for applications submitted online. 1 2 3 (iv) the contra-indications, the side effects and precautions if any; and You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. 1. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; (c) infant 35. 4.6 Duties of Production Incharges 6.3.1 Purchase Area of minimum of 200 square feet is required for the basic installation. (i) Country. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; (1) Disintegrator, where applicable. In order to avoid over-promotion, the main part of the volume of sales they generate. (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). Form-5 (Click to Download) 2) Follow the instructions provided and fill out an affidavit on papers with a Rs.50.00 stamp ( Click to Download- Affidavit ) 3) Make a deposit in a bank . of tablets, injections tubes litres etc. Proposed C and F and maximum retail price (in case of imported drug) : 6.6.4 Additional testing of reprocessed materials (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. (d) the approved therapeutic uses; Special provisions regarding grant of a licence: (1) Where a manufacturer intends to manufacture a drug a part of the process of which is of specialised nature and would be uneconomical for him to conduct it, the Central Licensing Board may permit such process to be undertaken at another licensed premises specialised for this purpose, subject to such conditions, if any, as may be specified in this behalf. 1. The well-qualified teachers help the students to develop skills needed to pass the examination. 6. FORM 3 (b) immediately upon receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f) of sub-rule (8); and (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Building Design And Construction (General) The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. (c) Uniformity of weight. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG 10.4 Batch packaging records SECTION -- 5 Degree or. Name of the Sample FORM 6 10. Serial Number, Use of vacuum 27. CHAPTER I - PRELIMINARY 551(1)//93, dated 3. Name of the drug. General (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. (g) Results of assay. General 3. (6) Hot air drying ovens. 20. (g) precautions, contra-indications and warnings; Prohibitions While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. 18. (i) Particulars regarding the legal status of the applicant (i.e. RECORDS OF RAW MATERIALS SCHEDULE E Certificate of registration: A certificate of registration of drug shall be issued in Form 6. Sodium Benzoate. III. 29. (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; (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; (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. (3) Employers shall be responsible for the statements and activities of their medical, representatives. 23. [See rule 2 (e)] 35. (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; By way of repacking Rs. 2.2 Terminally sterilized products Processing (d) Sterilisation. Airlock system (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 6.6 Rejected and recovered materials Sodium Metabisuphite. (9) The following information shall be supplied to the Registration Board-- (ii) Others (D) The following equipment is required for the manufacture of Powders :-- (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. 12. 3.7.1 System Sodium Carbonate. Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). 10.4.2 Pre-packaging line checks 6.2 Changing Rooms Captcha: 9 + 4 = Sign In. Each state may have different individual . Date of Registration Secretary Registration Board (Seal) Chairman. PROFORMA (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. Control reference numbers in respect of the lot of glass containers used for filling. (iv) licence to manufacture by way of repacking; and 2. Sterilized non-sterilizer products differentiation 10. Simulation of aseptic operations validation Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . Date of granulation wherever applicable. Analytical report number. Each of our licensure programs fulfils different pharmacists' needs. 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. (2) Capsule filling units. If drains are absolutely necessary they must not contract directly with waterways or public sewers, 7. Control reference numbers in respect of raw materials used. 2. (iii) Name of the drug(s) registered/approved. Frequency of use of filter (e) The Quality Control Department shall be independent of the manufacturing units and its incharge shall be a whole-time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry, or a degree in medicine, microbiology, pharmacology, or bacteriology from a university in Pakistan or any other institution recognised by the Federal Government for the purposes of Ordinance, as the Central Licensing Board may deem fit for any particular unit; and shall be independent of the incharge of the manufacture (Production Units). (iii) licence to manufacture by way of formulation; Zinc Sulphate. 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