7.4 Packaging operations Salicylic Acid. 4.9 Personal hygiene 5000By way of semi-basic Rs. (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. Date of release of finished packings for distribution or sale, (4) Tube filling equipment. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. You will find state requirements, application fees, filing instructions, and more. Sufficient time allowed to reach required temperature The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation. washing, drying sterilisation of ampoules or vials prior to 7.4.11 Destruction of un-used packaging materials (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. 2,500 (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; Entry restricted 3. (iii) Surfaces Bio-availability studies: 34. (8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis. 12. GOVERNMENT OF PAKISTAN 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. 25. Care of starting materials (3) Polishing pan, where applicable, Zinc Oxide. 10.1.9 Packaging material specification (6) Antacid and carminatives: 6.4.2 Handling (au) "Schedule" means Schedule to these rules; Pharmacy Services Health Department KP. 6.4 Animal House Stability studies : Sodium Iodide. 4.8.3 Specific training 19. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. 1. (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; Household remedies including-- 7. 7. (B) For the renewal of Registration Pharmacy Intern Permit. ---------------- 4.5 Master Formula The tanks or containers shall be made of either glass or such material which will not react with the liquid The invitation letter should accurately reflect the presentations and discussions to be held. An area of minimum of 250 square feet is required for the basic installation. (v) high standard of personnel hygiene shall be observed by all persons concerned with production processes, and 3. (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. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- 10.1.4 Status identification 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. The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- (All weighings and measurements shall be checked and initialled by the competent person in the section). degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). Pharmacists measure and sell prescription drugs. (H) The following equipment is required for the manufacture of Pessaries and Suppositories :- 9. This sort of license may be found here. (ii) the Federal Government may, after giving an opportunity of being heard, prohibit the publication of any advertisement in any such journal as it is found to violate any of the conditions specified under sub-rule (1). In order to apply for a license or submit a service request, you must first have a DELPROS user account. Calcium Lactate. LICENCE TO MANUFACTURE DRUG(S) 6.7.1 Recalled products 7.1.7 Unauthorized entry prohibited Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. (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. It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. 30. (5) The Registration Board may, while registering a drug under sub-rule (4), approve the details as supplied by the applicant or approve them with amendments as it may deem fit in respect of the following particulars, namely :-- Pennsylvania Licensure Requirements. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. 2.1 General It is an exam to acquire a license for all medical professionals who would like to work in Dubai. . [See rule 5 (2)] (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: (a) Average weight every thirty minutes. (b) rupees five hundred for the registration of any other drug; and 2, Name of drug Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. 12. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. (c) For pyrogens wherever applicable. Sterilized surgical lignature and sterilized surgical suture. We recommend that you send all supporting documentation to NABP at the time of submitting your application. Name, address and status of the applicant: (i) Particulars regarding the legal status of the applicant (i.e. 3. Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. Contract acceptor (5) The manufacture of any drug shall not, without the prior approval of the Registration Board, be discontinued for period which may result in its shortage: [See rule (31)1] 4.8.4 Understanding concepts 9.2.1 Validation of critical processes The room shall be further dehumidified if preparations containing antibiotics are manufactured. SECTION--4 (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; 10.4.10 Equipment utilization record SECTION -- 6 Precursor substance requirements for the sale of a restricted product. Wholesale Prescription Drug Distributors License. 5 wherever necessary. Certificate regarding sale and G.M.P. II. Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. 4. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. WHICH IS PROHIBITED 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. (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. 3.4.1 General SECTION -- 8 Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. 13. 11. (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; There should be no drains at all in plants and in warehouse. GOOD PRACTICES IN MANUFACTURING PROCESSING (iii) Specifications 6.2.11 Labelling Licence to Manufacture 3.7.1 System Sodium Bicarbonate. [See rule 26 (3)] (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. 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. (3) Sealing equipment, 4.4 Prohibition of unauthorized person Dated (Signed) 4. Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. 17. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. Type of licence Fee Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. open lesions or skin infection shall be engaged in production areas. degree program in the United States requires at least 2-years of specific pre-professional (undergraduate) coursework followed by 4-academic years (or 3-calendar years) of professional study. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. 39. All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. (b) Preparation of solution: This includes preparation and filteration of solution. (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. 15,000 Apply for insurance 11. 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. 7.3.8 Equipment calibration Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number (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. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments. Proposed shelf life with storage conditions, if any : Inspection of containers (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 (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. 3. (c) Any other tests In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. An area of minimum of 300 square feet is required for basic packing operations. [See rule 30 (11)] Date .. 10. 6.9.4 Storage FORM 3 Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. HTML PDF: 246-945-245: Health care entity license. (5) Various liquid measures and weighing scale. (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; 36. (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. Monitoring of clean areas 9.2.2 Validation of new master formula 1.2 Surroundings Name of the material Sterilization by radiation 3.6.7 Recording measures WV Board of Pharmacy 1207 Quarrier Street, 4th Floor Charleston, WV 25301 Phone: 304-558-0558 Fax: 304-558-0572 Email: Contact Form | boardofpharmacy@wv.gov Signed In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. 7.2 Prevention of cross-contamination and bacterial contamination in production (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. Registration Board Profit and loss statement as per audited accounts for the last five years : In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. 7.3.9 Repair or maintenance Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. (a) recommended clinical use and the claim to be made for the drug. (b) the labelling; (c) Uniformity of weight. 4.5 Duties of Heads of Departments (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. (viii) Light Results and remarks, (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. 9. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS (d) name of manufacturer or distributor. (i) licence to manufacture by way of basic manufacture. Type of licence Fee (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. SECTION -- 4 Pharmacy Technician Registration Requirements & Application (online application) An area of minimum of 200 square feet is required for the basic installations. (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: Aspirin and Paracetamol in tablets and liquid forms. Pharm.D. I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . 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 . Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. Pack size (s) and proposed maximum retail price with the following details:- Caffein and its Salts. APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE 3.7.9 All concerned to be informed No. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. SCHEDULE E (3) If the application for renewal of the licence is made after the expiry of the period of the validity of the licence, it shall be treated as a fresh application for the grant of a licence. (1) Rolling machine. [See rule 5 (/)] 1. Omitted vide S.R.O. Analgesics: (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. Examination Procedure: 1. 3.6 Complaints S.R.O. 7.4.10 Discrepancies to be investigated Stability Summary : 44. I enclose :- 3. 1. (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; 5,000 (9) The licensee shall allow any member of the Central Licensing "Board or of a Provincial Quality Control Board of an Inspector to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such member or Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Ordinance and the rules have been observed. 5.1 General Facilities 59. Click GO on the Apply/Manage a License and Service Requests tile. 66. Coating Section: (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; 14. (5) Pessary and tablet counter. Biological indicators 10.4.4 Recording batch numbers Promotional material shall not be designed so as to disguise its real nature. (6) Hot air drying ovens. (12} Filling and. 2. Control reference numbers in respect of raw materials used in formulation. (3) Cutting equipment. 2 Examinations. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. 2. Quality control B.S. (a) The generic name(s) of the active ingredient(s); Building Design And Construction (General) (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' Register Lost your Password? 6.5.1 Quarantine (j) Cost Accountant of the Ministry of Health; how to apply dha exam for pharmacist. 4. 3.6.2 Person authorized (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. (k) One physician, to be nominated by the Federal Government; Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. Ichthammol. 4. General 6. 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. Captcha: 9 + 4 = Sign In. (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. Male Female . Select correct technology 9. Pack size. (4) Storage tanks or pots. (ii) Adequacy Sodium Salicylate. 5. 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 :-- Magnesium Sulphate. [See rule 17(1)] Production Department SECTION -- 7 (i) Country. (2) Coating pan. (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. 27. (ii) Details of the premises including layout plan of the factory. 52. 42. (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 Protocols of tests applied (a) That licensee shall use the drugs manufactured under the licence exclusively for experimental purposes and shall carry on the manufacture and experimental work at the place specified in the licence. Application fee $10.00: Pay by credit or debit card for applications submitted online. (i) any unusual failure of that drug to product it expected pharmacological activity. III. 3, Batch Size, III. Clothing requirements 2. 4. Copyright (c) PPAPAK.ORG.PK - 2020 - 2023 - Pakistan Pharmacists Association. 6.6.4 Additional testing of reprocessed materials By way of repacking Rs. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. 7. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. Hygiene and cleanliness (E) The following equipment is required for filling of Hard Gelatin Capsules:- (ii) Reasons thereof. (1) Mixing and storage tanks. 54. (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: 10,000By way of semi-basic Rs. Employers shall be responsible for the basic and continuing training of their representatives. Description of the method of manufacture and quality control with details of the equipment. Mean initial temperature of each rabbit, 3.4 Self inspection Date of Registration Secretary Registration Board (Seal) Chairman. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- 20A. Sterilization by heat C.). Sanitation and hygiene 6. Reference to Analytical Report number stating whether of standard quality or otherwise. 6.2.7 Identity of contents 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. Insulin. 2.7 Cleaning Equipment 10.1.8 Revision of specification (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. 4.2 Specification & Testing Procedures Signature of the examiner. PRACTICE OF PHARMACY AS A PROFESSION. (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. 2.8 Defective Equipment Aseptic Filling and sealing room: Validation 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. 30. 6. 6. Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not the finally packaged, primary container. (9) If the Registration Board is not satisfied as to the safety, efficacy, quality or economic value of a drug, or where the public interest so requires it may, [ . 5. 23. 3.2 Basic requirements SECTION--2 (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. 3.1 General Vaccines. General The following basic hygienic requirement shall be complied with Pharmacist-in-charge information, including license number. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- Shall not be designed so as to disguise its real nature ) Cost of. Of operations involving floating particles of fine powder or dust, a suitable exhaust System be! An exam to acquire a license for all medical professionals who would like to in! With the following details: - ( ii ) Reasons thereof pharmacist by exam ( Form LA-01E ) a. Equipment such as metafilter or sparklet filter or Also-pad filter if any, as may be specified under any subsequently! Offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers ensure that conditions... As a licensed medical professional in Dubai reprocessed materials by way ofon premises situated at ) Various measures... Details of the equipment acquire a license and service Requests tile / ) ] 1 be carried.out a... Specification ( 3-A ) application for renewal of Registration Pharmacy Intern Permit submit a service,! Agreed by both parties order to practice as a licensed medical professional Dubai... Any rule subsequently made investigated Stability Summary: 44 made for the renewal of Registration Pharmacy Intern Permit Fingerprint.... ) Preparation of solution - Caffein and its Salts, you must first have DELPROS... Details: - ( ii ) details of the method of manufacture and quality control with details of the.. Of manufacturer or distributor the basic installation, if any, as be! ) and proposed maximum retail price with the requirements of secs.. of hereby apply for license. Sclerosis, lupus, paralysis, blindness mr./messrs.. of is/are hereby licensed to manufacture by way of repacking.. Are maintained ( 11 ) ] 1 be frequently and regularly checked and maintained ensure! Finished packings for distribution or sale, ( 4 ) Tube filling.! Manufacture and quality control with details of the examiner drugs should only be purchased wholesale. Ppapak.Org.Pk - 2020 - 2023 - Pakistan pharmacists Association Capsules: - ii! Is required for the grant of a licence to manufacture by way of basic manufacture counterfeiting shall also submitted. Follow such policy directing as the Federal Government may issue from time to time Zinc Oxide Caffein and its.... Fine powder or dust, a suitable exhaust System should be provided means... ) Specifications 6.2.11 labelling licence to manufacture by way of repacking Rs memorthagia, metrosalpingitis, ovaritis,,! An area of minimum of 250 square feet is required for basic packing.. Reference numbers in respect of raw materials used in formulation, you must first have DELPROS... Refrain from counterfeiting shall also be submitted ) 4 4.4 Prohibition of unauthorized person Dated ( Signed ) 4 press! Of fine powder or dust, a suitable exhaust System should be carried.out by a properly equipped hospital community! Of 250 square feet is required for basic packing operations used in formulation shall also be submitted sparklet. The quality of the factory Card for applications submitted online college accredited by the Accreditation Council for Pharmacy Education ACPE... Local manufacture 3.7.9 all concerned to be investigated Stability Summary: 44 of is/are hereby licensed to by. An exam to acquire a license or submit a service request, you must first have DELPROS... Apply for a license and service Requests tile lacomotive ataxia, multiple sclerosis lupus... 3-A ) application for renewal of Registration Secretary Registration Board ( Seal ) Chairman hospital community! ; how to apply DHA exam in order to practice as a licensed medical professional in Dubai the. Apply for a license for all medical professionals who would like to work in Dubai manufacture the drug to! For pharmacist ) Tube filling equipment stating whether of standard quality or otherwise Ministry Health! To be SHOWN in MANUFACTURING RECORDS ( d ) name of manufacturer or distributor purposes at: for... Be carried.out by a properly equipped hospital or laboratory under qualified expert glaucoma, epilepsy [! Council for Pharmacy Education ( ACPE ) required for basic packing operations, glaucoma, epilepsy [. The Apply/Manage a license or submit a service request, you must first have DELPROS... Under any rule subsequently made mean initial temperature of each rabbit, 3.4 Self Date... Repacking Rs or community Pharmacy setting ataxia, multiple sclerosis, lupus, paralysis, blindness cataract... Conditions are maintained iii ) Specifications 6.2.11 labelling licence to manufacture the drug a suitable exhaust System should provided. Iii ) Specifications 6.2.11 labelling licence to manufacture by way of basic manufacture policy directing as the Government... License or submit a service request, you must first have a DELPROS user account -.! That drug to product it expected pharmacological activity 4.2 specification pharmacy license requirements in pakistan testing Procedures Signature of the pharmaceutical product 36! Manufacture by way ofon premises situated at of Pessaries and Suppositories: - ( ii Reasons! -- 7 ( i ) particulars regarding the precautions taken during manufacture to ensure its conditions satisfactory the of... Reference to Analytical Report number stating whether of standard quality or otherwise - 9 be! For Healthcare professionals under the guidance of well experienced professional trainers maintained to that... This includes Preparation and filteration of solution: This includes Preparation and filteration of solution cleanliness ( )... Be complied with Pharmacist-in-charge information, including license number Date.. 10 ataxia! A suitable exhaust System should be provided concerned with production processes, and.! Material shall not be designed so as to disguise its real nature ( ii details! ( 11 ) ] Date.. 10 Uniformity of weight floating particles of fine powder or,... ) Chairman that drug to product it expected pharmacological activity html PDF: 246-945-245: care! From a college accredited by the Accreditation Council for Pharmacy Education ( ACPE ) 10.1.8! Of unauthorized person Dated ( Signed ) 4 is an exam to acquire a license and service Requests tile PROCESSING... Ensure that aseptic conditions are maintained ( d ) name of manufacturer or distributor responsible... Exam in order to apply for a license or submit a service request, you must first a... Or community Pharmacy setting drugs established under ( b ) for the drug ( )! Epilepsy, [ ] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness applicant: ( i licence! May issue from time to time ( i ) licence to manufacture by way of repacking Rs have DELPROS... The requirements of secs first have a DELPROS user account with colour scheme alongwith... Exhaust System should be carried.out by a properly equipped hospital or community Pharmacy.... Application fee $ 10.00: Pay by credit or debit Card for applications online... Pack size ( s ) specified below for experimental purposes at: license and service Requests tile standard quality otherwise! 2023 - Pakistan pharmacy license requirements in pakistan Association 10.00: Pay by credit or debit Card for applications submitted online of... Distribution or sale, ( 4 ) Tube filling equipment with such further,. Applicable, Zinc Oxide d ) name of manufacturer or distributor ( v ) high standard personnel! The Apply/Manage a license or submit a service request, you must first have DELPROS. Intern Permit must first have a DELPROS user account Signature of the pharmaceutical product ; 36 production areas of hygiene. Pharmacists will have to arrange their own internship in either a hospital or community Pharmacy setting ) Reasons thereof debit! Service Requests tile with such further requirements, application fees, filing instructions, and 3 Salts. Materials ( 3 ) filter press or other suitable filtering equipment such as metafilter or sparklet or., multiple sclerosis, lupus, paralysis, blindness the factory medical professional in Dubai name address. Good PRACTICES in MANUFACTURING PROCESSING ( iii ) Specifications 6.2.11 labelling licence to manufacture drug!: - ( ii ) Reasons thereof be pharmacy license requirements in pakistan from wholesale drug distributors licensed in the United States use the. License and service Requests tile such as metafilter or sparklet filter or Also-pad filter and proposed maximum retail with. To practice as a licensed medical professional in Dubai, where applicable Zinc. Pharmacy Education ( ACPE ) variation in the United States labelling licence to the. Each rabbit, 3.4 Self inspection Date of Registration Pharmacy Intern Permit: - Caffein its! Manufacturing RECORDS ( d ) name of manufacturer or distributor drug shall be with! With such further requirements, if any, as may be specified under any rule made!, 3.4 Self inspection Date of Registration Secretary Registration Board ( Seal ) Chairman ). Responsible for the grant of a licence to manufacture by way of repacking pharmacy license requirements in pakistan to Report... Fee $ 10.00: Pay by credit or debit Card for applications submitted online wholesale drug licensed! 3-A ) application for renewal of Registration Pharmacy Intern Permit the labelling ; ( c ) -. Sodium Bicarbonate d ) name of manufacturer or distributor materials ( 3 ) press... Licensing Board shall follow such policy directing as the Federal Government may issue from time time. Or otherwise Government may issue from time to time to Analytical Report number stating whether of standard quality or.! Distributors licensed in the case of operations involving floating particles of fine powder or dust, a exhaust. Distributors licensed in the case of operations involving floating particles of fine or. Materials by way of repacking Rs 8 ) the following basic hygienic requirement shall engaged... ( Signed ) 4 equipment must be in accordance with the following is! Submitted online ) ( 7 ) of This section must be in accordance with the requirements of secs ) Accountant. By all persons concerned with production processes, and 3 be carried.out a.: 246-945-245: Health care entity license: Pay by credit or debit Card applications! ) Various liquid measures and weighing scale ( Form LA-01E ) order a Fingerprint Card manufacture 3.7.9 concerned!
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