pharmacy license requirements in pakistanpharmacy license requirements in pakistan

(d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. (3) An application under sub-rule (1) shall be accompanied by fee or-- 4. [See rule 26 (1)] Verification of Licensure - If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure will be required to be submitted directly to this office by the licensing agency of any state of the United States in which you hold or ever held a license. 15. Name of the Sample CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation Batch number. ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG (a) the name under which the drug may be sold; 5.3 General Requirements for Production Areas SCHEDULE B-I 41. 2. (See rules 19 and 30) Name of the sample. Certificate regarding sale and G.M.P. (a) Average weight every thirty minutes. 10.1.5 Product labelling Frequency of use of filter Application fee for Advertisement. (1) Hot air oven electrically heated with thermostatic control. Details of Disposal Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . Pay your fees using internationally accredited credit cards e.g. Universal Licensing Requirements. 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products. (5) Mixing and storage tanks of stainless steel or of other suitable material. 5,000 There should be no drains at all in plants and in warehouse. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. 19. Test Report number. 11. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; DRUG REGISTRATION FEE (a) recommended clinical use and the claim to be made for the drug. The following basic hygienic requirement shall be complied with 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver. Cough Preparations. Control reference numbers in respect of raw materials used. 15. 6.6.4 Additional testing of reprocessed materials 31. Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- [See rule 20 (b)] (b) rupees five hundred for the registration of any other drug; and (a) Generic international non-proprietory name: (i) 10,000 Sulphonilamide Powder (B. VET. I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . Conditions for Advertising: (1) The Federal Government may, after seeking advice of the Committee on Advertising, allow the advertisement of a drug, or any substance or a remedy as specified in Schedule D-1 or a treatment or offer of a treatment for any disease. Sodium Chloride. 1. Aseptic Filling and sealing room: Ferric Ammonium Citrate. Apply for insurance 11. 6. 2,500 (ii) the route of administration; 5. 1. of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. 2. 10.3.1 General (i) adequate facilities for first aid; Antigen. Name of Manufacturer. ST-PHARMACY@PA.GOV. Pharmacological and clinical data : 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), 3. (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control; Attested copies of the last two income tax assessment orders of the Income Tax Department attached. 6.2.8 Released materials to be used 9. The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. (2) Moulding equipment. Pharmacist Exam and License. Select correct technology 9. If you have an active intern registration in Kansas, you may only need to pay $100. 4.9.5 Avoiding direct contact with materials 3.3.2 Sampling RECORDS OF RAW MATERIALS 16. Sterilization of gases used 9. 3. Control reference numbers in respect of raw materials used in formulation. 4. The drug(s) or class(es) of drugs intended to be manufactured :- SECTION -- 10 (8) Hot Air Steriliser, Register Your Self. 3.3.6 Production record/batch review Box 2649. (8) Autoclave. Records of the disposal of rejected batch and batches with-drawn from the market. Simulation of aseptic operations validation Comparison of products shall be factual, fair and capable of substantiation. 5.2 Hygiene Manufacture of sterile preparations 50.00 stamp papers as prescribed ( Click to Download- Affidavit) New processes to be validated 12. I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. (r) "Form" means a form set forth in Schedule A; (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. 9.1 General 44. Proposed route of administration. 1. 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. 9. APPLICATION FORM FOR RENEWAL OF REGISTRATION OF ALL KINDS OF DRUGS (2) A drug or any substance referred to in clause (ii) of Sec. 47. Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : An area of minimum of 250 square feet is required for the basic installation. Pennsylvania Licensure Requirements. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. (iv) the contra-indications, the side effects and precautions if any; and 14. 3.7.8 Storage of recalled drugs (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. (ii) Testing Procedures (2) Kettles, steam, gas or electrically heated. Tableting Section: Name of drug. (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. Drug Regulatory Authority of Pakistan. (4) Water still. Name of the sample 3. (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; 4, Date of receipt of sample. (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; (g) any failure of one or more distributed batches of that drug to meet the required specifications; This room shall be air-conditioned. license by examination or by license transfer the applicants who are qualified to engage in the practice of . The importation into Panama of narcotic, controlled and restricted drugs is subject to import licensing to ensure that traders' procedures are in conformity with Panama's international obligations (Single Convention on Narcotic Drugs 1961 and Convention on Psychotropic Substances 1981). 6. III. (2) Ampoule washing and drying equipment. Ensure contact between gas and microbial cells (ii) Batch number(s) Any drug so permitted to be manufactured by the Central Licensing. The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule. Biological indicators (5) Various liquid measures and weighing scale. (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug. SCHEDULE B (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and Signature of the Analyst, Whether the drug is registered for local manufacture or import 13. 17. 2. 3 Name under which drug is proposed to be sold Short title and commencement: . 9.2.3 Validation of equipment if materials It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- Examination Procedure: 1. 7. Salicylic Acid. You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. Hygiene and cleanliness [See rule 16 (6) (b)] Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). Monitoring each cycle Type of licence Fee and (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). (5) Mixing and preparation tanks or other containers. The application fee is $147. 8. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; Outside contractor (ii) Details of the premises including layout plan of the factory. prevent, the entry of air from outside. 10. Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. 2.2 Terminally sterilized products 1.Analytical report number 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. Date of issue .. 3. 1. SCHEDULE B I-A. 6.1.1 Quarantine 1. 5.1 General Facilities 2. 4.9.4 Reporting health problems (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and 3. 2. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. 2. How to get Category A pharmacy license in Pakistan? To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. (2) Capsule filling units. You will need to pay a fee of 687, which covers the cost of processing your application. 10,000By way of semi-basic Rs. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- (4) Water still or Deioniser. 1500 Hours of Experience. Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and Validation General PROFORMA (a) animal or clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning Phone - (717) 783-7156. 3. Sec. Total. 4.8 Training 2.6 Filters PREMISES 12. 6.3 Packaging materials 23. The following equipment required :- 6.9.3 Working standards Sera. APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG Ephedrine Hadrochloride. DETAILS OF THE FIRM Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. (4) Oven thermostatically controlled. Our licensure programs align with board of pharmacy requirements and streamline processes for pharmacists, technicians, interns, and seeking to practice in additional states, whether it is permanent or in response to a public health emergency. Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or Sterilization by ethylene oxide Sena. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board. The word "safe" shall not be used with respect to promotion unless properly qualified. Statement of the Central Research Fund. Entry restricted 24. All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. (2) Trimming machine. 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