pharmacy license requirements in pakistan

As a first step, your business must obtain a resident or in-state pharmacy license from your state's licensing agency. 6.1 Material, general (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. RECORDS OF RAW MATERIALS Control reference numbers in respect of raw materials used. [See rule 31 (1A) and (1B)] 7. 4.6 Packaging Instructions (ii) Batch number(s) Soft yellow Paraffin. (6) The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical, pharmacological and other aspects, to be conducted and clinical trials to be made as are necessary to establish its quality and, where applicable, the biological, availability, and its safety and efficacy to be established under the local conditions: DRUGS FOR REPACKING 9.1 General (4) Water still. Nebraska Governor Pete Ricketts recently signed Executive Order No. (iii) Name of the drug(s) registered/approved. 2. 35. (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. 6. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. Pharmacy (In-State Only) License. (a) Preparations of the container: This includes, cutting. 3. Justification : (Only in case of a new entity). (1) Mixing and pouring equipment. 2.1 General 10. (iv) Services The text shall be fully legible. (2) They shall come into force at once. 5. Safety instructions should be strategically displayed in local language. (i) licence to manufacture by way of basic manufacture. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. (f) Any other tests. 7.1.1 General Pharmacist-in-charge information, including license number. Find funding 5. [See rule 26(I)] Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). The word "safe" shall not be used with respect to promotion unless properly qualified. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- (2) Mixer. [See rule (31)1] A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. (b) rupees five hundred for the registration of any other drug; and Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling to be nominated by the Federal Government. Signature of the Analyst. 6. A. Tablets and capsules: Rs. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. 12. (1) Mixing equipment. 3. Sterilized surgical lignature and sterilized surgical suture. (1) Sifter. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate (7) (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund; Processing (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. 3, Batch Size, Signature of the Analyst. Personnel This room shall be air-conditioned. [See rule 5 (2)] 4.1 Capacity Calcium Carbonate. (2) Graduated delivery equipment for measurement of the medicament. 3. Water supply 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. 3.4.6 Follow-up Action CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. Please contact the Board at pharmacy@ks.gov for more information. The BPS Board Certified Pharmacotherapy Specialist (BCPS) program is a credential for pharmacists who have met the eligibility criteria below and who in their unique practice ensure the safe, appropriate, and economical use of medications as part of interprofessional treatment teams in a variety of settings, including hospitals and health systems. (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; Number of container packed (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. {4) Heater and exhaust system, where applicable. Captcha: 9 + 4 = Sign In. Pharmacy Intern Permit. 3.7.6 Recording and progress 3.7.9 All concerned to be informed Sterility test as the last measures 43. Filtration of pharmaceutical products that cannot be sterilized in the final container Sena. (a) For the grant of licence: 4.3 Specifications for Starting and Packaging Materials 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. 10.1 Documents Analytical report number. (4) Tube filling equipment. Prescribers and dispenses shall not solicit such inducements. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. 7.4.4 Process continuity 6.2.1 Purchase 6. Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible. III. 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. (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; 9. Potassium Bicarb. Sanitation and hygiene 38. Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, Records of test to be carried out in case of tablets as under (iv) hygienic garments shall be worn by all staff in processing and packaging areas; 1. (1) Class(es) of drugs. The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. Proposed route of administration: [See rule 21(I)] 9. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at (14) Leak tasting equipment. 9.2 Process validation Calculated Paid investment Turnover (a) Generic/international non-proprietary name: (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. 6. 4.8 S.O.Ps for Testing 3. (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. Liquid Paraffin Heavy. 3.4 Facilities 4. CRF due C R F paid as per Col. 41 2 3 4 5 Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan. of Pack Total quantity in terms of individual units e.g., total No. Ichthammol. 1. (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. . 6.11 Miscellaneous (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate how to apply dha exam for pharmacist. Equilibrium with humidity and temperature Magnesium Hydroxide. Name of the sample. SECTION-I (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. (d) special groups, The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. 67. (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. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. 190.00 Renewal Fee. 7. 7. Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. 6. 9. 5. Provided that under special circumstances to be recorded in writing, the Registration Board may register a drug and require such investigations and clinical trials to be conducted after its registration. General Room: Preparation of live organisms (i) Country. Inspection of containers (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; [See rule 26 (3)] 41. General 7. Note: Copies of balance sheets to be enclosed with the application for renewal only"; and By way of basic Rs. Duration: 2 years, annual system, NTS based examination Eligibility: 7.2 Prevention of cross-contamination and bacterial contamination in production 40. 5.3 General Requirements for Production Areas 6.2.10 Checking Both are non-refundable. 1. Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. Order No a drug shall be made in Form 5-B, Bio-equivalence and Analysis! Apply for the renewal of registration of a drug shall be made in Form 5-B deterioration in any Batch that... 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