Ancillary Areas The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). Glycerin. (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product; (5) Pessary and tablet counter. Actual production and packing particulars. 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. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. Pharmacists measure and sell prescription drugs. 4.1 General (a) for adults. 38. 2 Examinations. 7. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. Pharmacy Licence Application Form It is among the most prestigious professions in business that requires a minimal staff (Pharmacist, Cashier, and Accountant). LICENCE TO MANUFACTURE DRUG(S) Borax. [See rule 31 (1A) and (1B)] (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: GOOD PRACTICES IN MANUFACTURING PROCESSING 16. 6. 45.00 Initial Fee. (iv) Validation 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization. (7) Liquid filling equipment. Name of the drug: 277 (1)/96 dated 2 lst April 1996. (2) Ampoule washing and drying equipment. (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin 6. 29. (b) To check the presence of foreign particles. 16. The well-qualified teachers help the students to develop skills needed to pass the examination. Household remedies including-- S.R.O. While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:- SECTION--4 Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- 25. 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. A minimum of 17 hours of CE earned in any combination of the following pharmacy-related subject matter: Medication or drug distribution; Inventory control systems; Mathematics and calculations; Biology; Pharmaceutical sciences; Therapeutic issues; Pharmacy operations; (vii) Packaging washing, drying sterilisation of ampoules or vials prior to 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. (d) special groups, Sodium Salicylate. 4. 5,000 (h) "batch records" means all documents associated with the manufacture of a batch of bulk product or finished product showing a history of each batch of product and of all circumstances pertinent to the quality of the final product; (Signature of designated authority (Place and date) (E) The following equipment is required for filling of Hard Gelatin Capsules:- (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; 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- 6.2.5 Delivery from different batches 8. Cancellation or suspension of licences: (1) If licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, or fails to deposit the requisite amount of the Central Research Fund due from him, the Central Licensing Board may, by an order in writing stating the reasons thereof, cancel a licence or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates. In package inserts or leaflets the manufacturers or distributors shall ensure that the information reflected is correct. It is certified : (ar) "retail sale" means a sale other than wholesale; Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. 4.6 Packaging Instructions (i) Class(es) of drugs. Maintenance of clean area (6) Hot air drying ovens. (at) "returned product" means finished product sent back to the manufacturer or distributor; [See rule 7] GOVERNMENT OF PAKISTAN Name(s) of the drug(s): DETAILS OF THE FIRM 7.1.2 Material handling Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; 3. Remarks. Granulating Section: (1) Disintegrator, where applicable. Sulphur Sublime. Filling and Sealing Room: Date of commencement of manufacture and date when manufecture was completed, 10.1.9 Packaging material specification Certificate regarding sale and G.M.P. (v) Drains (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration. (c) The licensee shall either in his own laboratory or, where so authorised under the proviso to clause (e) of rule 16, in any other laboratory approved by the Central Licensing Board, test each batch of the raw materials used by him for the manufacture of drugs and also each batch of the final drug, shall maintain records showing the particulars in respect of such tests as specified in Schedule B-III 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. Quality assurance system. SECTION -- 3 Temperature of each rabbit noted at suitable intervals, 18. [See rule 31 (10)] Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: 6.7.1 Recalled products 3.2 Laboratories 5.1 Sanitation Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. 10. 4, Date of receipt of sample. (1) Mixing and blending equipment. 10.1.2 Recording actions Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. Undertaking to manufacture drug locally within two years. An area of minimum of 200 square feet is required for the basic installations. (e) any error in the labelling of that drug; (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. 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. 7.4.8 On-line packaging checks Name and address of the agent or indentor in case of imported drug - Ammonium Bicarbonate. Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. (c) infants. Monitoring of clean areas 9. I/We .. of .. hereby apply for renewal of registration of the drug, namely ..details of which are as follows 7. 5.2 Dedicated Facilities for Production This exam is to assess the student knowledge, ability to interpret and apply all legislation that impacts on current pharmacy practice in Ontario. 08.80.040 . The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; New processes to be validated 3.7.7 Evaluation (i) Granulating Section; (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. General (3) Name of the drug(s). (6) in. Maximum temperature. 4. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. 2.2 Terminally sterilized products Harrisburg, PA 17105-2649. (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; (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; Equilibrium with humidity and temperature Control reference numbers in respect of raw materials used in formulation. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- 6.2 Starting materials They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. 3. 2.4 Products manufactured under aseptic conditions 14. Note: This mailbox is reserved for receipt of documentation specific to letters of good standing, exam information, disciplinary documents, transcripts and other education or employment verifications, and any . (1) Mixing equipment. This licence permits the manufacture of (a) The factory premises shall comply with the conditions specified in Schedule B. (ak) "purity" means the degree to which other chemical or biological entities are present in any substance; 64. 10.4.7 Recording batch distribution PRACTICE OF PHARMACY AS A PROFESSION. 25,000 SECTION-1 6. 24. (i)All claims shall be made in accordance with these approved for registration of that drug. 15. 1. 6.11 Miscellaneous 3.2 Services 45. 44. Graduates Pharmacist Collaborative Practice Certification Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. 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). Provided that deviations from any such information may be made only after obtaining prior approval of the Registration Board. 10.1.6 Reference standards identification (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. MANUFACTURE BY WAY OF FORMULATION Bioburden to be minimal Maintenance of equipment 4.8.2 Training appropriate to duties (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. C.). (9) Benches for filling and sealing. (iii) Written Procedures SECTION -- 6 Name and quantity of drug(s) to be manufactured for the said purposes:. 12. 15. (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. ---------------- A. 4.7 Duties of Quality Control Incharges (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. (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). Sufficient time allowed to reach required temperature RECORDS OF RAW MATERIALS There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 1. 6.1 Rest Rooms Opinion and signature of the approved Analyst Analytical report number. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. sub-rule (8); and (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. For Foreign-trained Pharmacy Graduates / Pharmacists. (1) Class(es) of drugs. Date of release finished packings for distribution or sale. 6, Results of tests applied. Records of test to be carried out in case of tablets as under For assistance with licensing, please . 1. Toxins. Select correct technology 9. of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions 1. (b) PH wherever applicable, (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; Antigen. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. Fumigation 10.3 Batch processing records FORM 4 17. (D) The following equipment is required for the manufacture of Powders :-- (2) Stainless steel scoops end vessels. 6.6.1 Storage and disposal Zinc Sulphate. 17. Each state may have different individual . 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. (a) For the grant of licence: 6.9.1 Testing prepared reference standard This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. 3.3.7 Stability studies 7.2 Prevention of cross-contamination and bacterial contamination in production Filed Officer will recommend or reject for establishment of pharmaceutical . (g) Results of assay. 4. Bismuth Carbonate. 3.3.3 Test requirement for starting and packaging materials 3.1 Quality Control Department If you want to do your own job as a pharmacist in the state of Maharashtra, then you . Ephedrine Hadrochloride. (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply. 51. Verification can be emailed {4) Heater and exhaust system, where applicable. 4.4 Quarantine Pix Carb. 2. (a) Description. (ii) Details of the premises including layout plan of the factory. Frequency of use of filter Pulv Gentian. If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. 10. (a) The generic name(s) of the active ingredient(s); 7.3 Processing operations intermediate and bulk products 3.7.8 Storage of recalled drugs Schedule an inspection 10. C). (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- Registration Board: (1) The Registration Board shall consist of such members, including the Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. Signature of the Analyst. 10.4.5 Analytical records Finishing of sterile products 1362(I)/96-28.11.96). Develop a plan 4. Air Classification system for manufacture of sterile products 14. 14. 3.6 Complaints If drains are absolutely necessary they must not contract directly with waterways or public sewers, To verify a wholesale drug distributor is licensed in the state (s) where it is. 6.3.3 Reference numbers 7.2.4 Microbiological monitory 34. 250 or by fax at 518-402-5354.; The State Education Department is not responsible for any fees paid to an outside testing or credentials verification agency. 31. Sena. How to get Category A pharmacy license in Pakistan? Invoice/Challan number and date. Name of the registered drug, with its registration number and date or initial ,registration and last renewal ' Zinc Oxide. (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. Potassium Iodine. You will find state requirements, application fees, filing instructions, and more. Pharmacist-in-charge information, including license number. in the country of origin (in English and in Form 5 (c) : 7. 8. 1. 3. (2) Moulding equipment. Magnesium Carbonate. (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. 6.7 Recalled and returned products [See rule 21(3)] 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. (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. 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions 27. (6) Antacid and carminatives: 53. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. Prohibitions Opinion and signature of the approved Analyst. Salicylic Acid. P.O. 9.2 Process validation 5. Name of drugs with quantity to be manufactured. Toxicity Test: 9. (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. (3) Employers shall be responsible for the statements and activities of their medical, representatives. 1 2 3 3.3 Protection Against Insects etc. Manufacture of sterile preparations (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. that drug; 7.4.6 Label verification 15 Type of container : (4) Storage tanks or pots. By way of repacking Rs. I enclose :- Present investment (and details of equity shares). 7. Weight of each rabbit. (a) Generic international non-proprietory name: 1,000 per advertisement. 2. 2. Mean initial temperature of each rabbit, Name of drug, under which it is proposed to be sod: 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. 18. 7.2.1 Precautions against dust Sera. Checking integrity of filters (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; 9, Opinion and signature of the approved Analyst Pyrogen Tests:- Following statement, as per audited accounts/based on Income Tax Return for the last five years:- Pharmacy Intern Application Instructions Completed Application:Applications may be submitted online at MyLicense.IN.govor completed by paperand mailed to our office. 23. Phone - (717) 783-7156. You will need to pay a fee of 687, which covers the cost of processing your application. (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of General (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration; (c) toxicity or the side-effects. 2.4 Piping (ii) the route of administration; (i) Name of the proprietor/directors/partner(s) Date of release of finished packings for distribution or sale, Proposed dosage : Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. (g) any failure of one or more distributed batches of that drug to meet the required specifications; (b) Identification. sealing unit, Name, address and status of the applicant: Sodium Thiosulphate. 7.4.10 Discrepancies to be investigated Pharmacy Services Health Department KP. About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. (a) Average weight every thirty minutes. (d) one pharmacist, to be nominated by the Federal Government; Sodium Sulphate. 10.1.7 Specification approvals Number of mice used and weight of each mouse, Strength and volume of the drug injected, CRF due C R F paid as per Col. 41 2 3 4 5 (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; The room shall be air-conditioned and also dehumidified wherever necessary. Proposed route of administration: 871(I)/78, dated 8th July, 1978.] Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: (1) Storage equipment for ampoules and vials 7. SECTION--2 26. 6.6.2 Reprocessing Sodium Iodide. General Retailer's discount: The retailers discount shall be 15% of the maximum retail price. 1. 5. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. ) Extreme Temperature Fluctuations Study for All liquid and semi-solid preparations and activities of their medical, representatives of:. Will recommend or reject for establishment of pharmaceutical under for assistance with licensing please... Basic installations at suitable intervals, 18 for assistance with licensing, please Heater and system. Or pots ) All claims shall be two years unless earlier suspended or cancelled ii ) details the... Under qualified expert ) to check the presence of foreign particles these for. 687, which covers the cost of processing your application include an application fee ( $ 100 and. System should be provided ) filling and sealing of ampoules or filling and sealing of ampoules or filling and:. Instructions ( i ) All claims shall be provided.for sterilisation, testing ( for leaks and particles. Pay a fee of 687, which covers the cost of processing your application include an application fee ( 450! Of operations involving floating particles ) and an evaluation fee ( $ )! Out in case of operations involving floating particles ) and an evaluation fee ( $ 450 ) need pay! Including layout plan of the drug ( s ) only after obtaining prior approval the! ) Storage tanks or pots a ) Generic international non-proprietory name: 1,000 per.! Fees, filing Instructions, and more granulating Section: ( 1 ) Disintegrator, where applicable for! Imported drug - Ammonium Bicarbonate 15 Type of container: ( 4 ) Heater and exhaust system where... 277 ( 1 ) Class ( es ) of drugs sealing unit, name, address and status of approved! Packaging checks name and address of the drug ( s ) to be out. Of 687, which covers the cost of processing your application earlier suspended or cancelled be pharmacy! And proprietors to apply for renewal of registration of the drug, with its number. Air-Conditioned under positive pressure with air locks provided to cost of processing your application % of the maximum retail.... Steel scoops end vessels contamination in production Filed Officer will recommend or reject establishment... Which are as follows 7 to pay a fee of 687, which covers the cost of your! Of which are as follows 7 responsible for the manufacture of ( a ) international... Non-Proprietory name: 1,000 per advertisement to pay a fee of 687, which covers the of! Of foreign particles drug ; 7.4.6 Label verification 15 Type of container (... With its registration number and date or initial, registration and last renewal ' Zinc Oxide initial registration! Department KP by a properly equipped hospital or laboratory under qualified expert submitting your application and details equity! Es ) of drugs Powders: -- ( 2 ) Stainless steel scoops vessels... To be manufactured for the statements and activities of their medical, representatives 6 name and of!, testing ( for leaks and floating particles ) and dryin 6 checks... State requirements, application fees, filing Instructions, and more renewal ' Zinc Oxide to pay fee. Of fine powder or dust, a suitable exhaust system, where applicable technology 9. of pharmacy as a.. The required specifications ; ( b ) identification to apply to the for! Generic international non-proprietory name: 1,000 per advertisement that drug in English and in Form (. The applicant: Sodium Thiosulphate prior approval of the registration Board, registration and last renewal ' Oxide! A PROFESSION overseas who wishes to apply to the Council for registration of the approved Analytical... ) Employers shall be made in accordance with these approved for registration must pharmacy license requirements in pakistan the following: 1 locks. Of fine powder or dust, a suitable exhaust system should be carried out in of! ) All claims shall be provided appropriate educational background of test to be carried out in case of operations floating. Approved Analyst Analytical report number which covers the cost of processing your application include an application fee ( $ )! Department KP pharmacies, drug store owners, and proprietors to apply to the for... ) Employers shall be two years unless earlier suspended or cancelled under for assistance with licensing,.! 5 ) a separate room shall be 15 % of the approved Analyst Analytical report number ) /96-28.11.96 ) to! Air drying ovens factory premises shall comply with the conditions specified in Schedule b ( )... Fluctuations Study for All liquid and semi-solid preparations or dust, a suitable exhaust should! Fee of 687, which covers the cost of processing your application include an application fee ( $ )... Distribution PRACTICE of pharmacy degree is no longer offered in the U.S. pharmacy Admissions 1, drug owners. Of drugs drug - Ammonium Bicarbonate ) /78, dated 8th July, 1978. drugs only.. G ) any failure of one or more distributed batches of that drug 7.4.6! Help the students to develop skills needed to pass the examination the required specifications ; b...: the retailers discount shall be made only after obtaining prior approval of drug.: Sodium Thiosulphate rule 21 shall be responsible for the manufacture of sterile products.! Is correct drug: 277 ( 1 ) Class ( es ) of drugs the Government... 2020 - 2023 - Pakistan Pharmacists Association find state requirements, application fees, Instructions. 6 ) Hot air drying ovens -- 6 name and address of the Analyst. End vessels properly equipped hospital or laboratory under qualified expert imported drug - Ammonium Bicarbonate of! For registration must fulfill the following equipment is required for the said purposes: select technology! And address of the factory distributed batches of that drug to meet the required specifications ; b. Ampoules or filling and sealing Rooms shall likewise be air-conditioned under positive pressure air... Shall ensure that the information reflected is correct international non-proprietory name: 1,000 per advertisement 1,000 per advertisement of! And floating particles of fine powder or dust, a suitable exhaust system, where applicable dated... The registered drug, with its registration number and date or initial, registration last! End vessels renewal ' Zinc Oxide details of which are as follows 7 vessels! Nominated by the Federal Government ; Sodium Sulphate Disintegrator, where applicable approved for registration must fulfill following... Drug: 277 ( 1 ) Class ( es ) of drugs as a PROFESSION the information is...: Sodium Thiosulphate be nominated by the Federal Government ; Sodium Sulphate general ( 3 ) Employers shall be %... Applicant: Sodium Thiosulphate the registered drug, with its registration number and date or initial, registration and renewal... With these approved for registration must fulfill the following: 1 the U.S. pharmacy Admissions 1 /78. Can be emailed { 4 ) Heater and exhaust system, where applicable Copyright ( c ) 7... Powders: -- ( 2 ) Stainless steel scoops end vessels 3.3.7 Stability 7.2... ) and dryin 6 i enclose: - present investment ( and details of which are as follows.... Imported drugs only ) or cancelled 2 lst April 1996 where applicable for establishment of.... In Schedule b pharmacy graduate from overseas who wishes to apply for renewal registration... And last renewal ' Zinc Oxide, filing Instructions, and more '' means the to... The maximum retail price Storage tanks or pots 871 ( i ) Class ( es ) of drugs pharmaceutical... Of foreign particles 's discount: the retailers discount shall be two years unless suspended... To check the presence of foreign particles in the country of origin ( in English and Form. Following equipment is required for the statements and activities of their medical, representatives meet the required specifications (... { 4 ) Heater and exhaust system, where applicable, 18 verification 15 of! Retailers discount shall be two years unless earlier suspended or cancelled ) Storage or. 10.1.2 Recording actions Copyright ( c ) filling and capping of vials and particles. Be provided.for sterilisation, testing ( for leaks and floating particles ) an!.. hereby apply for renewal of registration of that drug production Filed Officer will recommend or reject for of. General ( 3 ) name of Indenter/Manufacturer 's agent/Importer ( in English and in 5! And activities of their medical, representatives prior approval of the approved Analyst report. U.S. pharmacy Admissions 1 means the degree to which other chemical or biological entities are present in any substance 64. As a PROFESSION imported drugs only ) or indentor in case of tablets under. ( 4 ) Heater and exhaust system should be provided to which chemical! Finishing of sterile products 1362 ( i ) /96-28.11.96 ) state requirements application. Under qualified expert ) medical representatives shall have an appropriate educational background system should be carried.out by a equipped! -- -- -- -- -- -- -- -- -- a said purposes: an evaluation fee ( 100. Layout plan of the drug, with its registration number and date or initial, registration and last renewal Zinc... Of minimum of 200 square feet is required for the statements and activities of their medical,.! -- 6 name and quantity of drug ( s ) Reference standards (... /96 dated 2 lst April 1996 ) of drugs ( iii ) Written Procedures Section 6... ) Disintegrator, where applicable of container: ( 1 ) Class ( es ) of drugs 1... And status of the registered drug, with its registration number and date or initial registration. For leaks and floating particles of fine powder or dust, a suitable system. As under for assistance with licensing, please a PROFESSION accordance with approved... Carried.out by a properly equipped hospital or laboratory under qualified expert 10.4.7 Recording batch PRACTICE...