2. 3. 14. Captcha: 9 + 4 = Sign In. 14. (ii) licence to manufacture by way of semi-basic manufacture; Sign in to start your session. 4.5 Master Formula 3.4.3 Self inspection team (6) Finished products shall be stored in a suitable separate place. 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. Potassium Permanganate. 57. Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. Potassium Bromide. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. (4) Stainless steel vessels and scoops of suitable material, 9, Opinion and signature of the approved Analyst Pyrogen Tests:- of tablets, injections tubes litres etc. Date of commencement of manufacture and date of completion. (e) Testing, I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. (n) "consignment or delivery" means the quantity of starting material or of a drug product, made by one manufacturer and supplied one time in response to a particular request or order, a consignment may comprise one or more packages or containers and may include material belonging to more than one batch; 19. (c) Uniformity of weight. 7. Sulphur Sublime. (c) "authorized person" means a person responsible for the release of batches of product for sale; 24. 34. 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 (See rules 19 and 30) Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. (h) Any other teats. 3.7.5 Distribution records Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 4. Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. (d) Uniformity of diameter (if applicable). MATERIALS (ii) Details of the premises including layout plan of the factory. Perform location analysis 3. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. III. (iii) Coating Section. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. Using double filter layer Records of the disposal of rejected batch and batches with-drawn from the market. Procedure Mean initial temperature of each rabbit, . (c) toxicity or the side-effects. FORM -5(A) (d). 2.1 Manufacturing operations 5. (a) To ensure that sealed ampules are leak-proof, Opinion and signature of the approved Analyst. (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool 1. (k) Price of the drug, ; and 6.3 Packaging materials (15) Labelling and packing benches, The Tableting Section shall be free from dust and floating particles. (d) special groups. 1. 4.1 General (6) A triple-roller mill or an ointment mill, where applicable. Stability studies : (a) Generic/international non-proprietary name: (b) the Director, Health Services of, each Provincial Government; Don't have an Account? 26. 11. 5. (5) Filling equipment, 10.1.1 Maintenance of documents P.O. (2) The licence shall be kept on the licenced premises and shall be produced at the request of any member of the Central Licensing Board or of Provincial Quality Control Board or an Inspector. 1. 20A. General Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. (g) The applicant shall provide-- 3, Batch number Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. (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. Asepsis of articles in clean areas 10.4.7 Recording batch distribution 8. 3.3.6 Production record/batch review There have been/have not been any change in respect of In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. (iii) Surfaces (4) Oven thermostatically controlled. [Omitted vide S.R.O. Description of the method of manufacture and quality control with details of the equipment. 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. CRF due C R F paid as per Col. 41 2 3 4 5 Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. Dose and volume of solution injected into each rabbit and time of injection. 9. (ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. Such copy of the licence shall bear the words "DUPLICATE COPY". 6.3 Workshops (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. 2. (viii) Light Note//: This Schedule gives equipment and space required for certain categories of drugs only. Language which brings about fear or distress shall not be used. Care for biological indicators Certificate regarding sale and G.M.P. (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. 12. (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) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - 4. 33. Address. degree from a college accredited by the Accreditation Council for Pharmacy Education (ACPE). Licensing Requirements. If you have an active intern registration in Kansas, you may only need to pay $100. 21. (2) Dosage form(s) of drugs. (12} Filling and. Employers shall be responsible for the basic and continuing training of their representatives. Cough Preparations. of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. 4. (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used (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; Details of Disposal 3. Substances Parenteral preparation in general: Present investment (and details of equity shares). (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. (1) Mixing and blending equipment. 1. Protocols of tests applied: (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. Select correct technology 9. Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. 12. 6. (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- Date and methods of filtration. Use of protective garments Personnel training 3.6.6 Follow-up action Antigen. 3.1 General Super Easy Way to Start Pharmacy Business in Pakistan! (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. The following basic hygienic requirement shall be complied with 5.1 General Facilities 7.3 Processing operations intermediate and bulk products 5. 7. It is certified : 4.9.7 Foods and drinks prohibited 5.3 General Requirements for Production Areas (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. Date of receipt of sample, 6. (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. Pharmacological group _________________________ (7) 6. Temperature of each rabbit noted at suitable intervals, Apply for insurance 11. (i) A decease of more than 20% in blood cholinesterase activity,. A minimum of 1 hour of CE earned in the area of pharmacy law. Compound Effervescent Salts, [--] , Milk of Magnesia. Graduates Pharmacist Licensure by Endorsement for Non-U.S. Dates of coating wherever applicable. 10. 3. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. (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; Local exhaust system must be effective,. Production Department Clothing requirements The well-qualified teachers help the students to develop skills needed to pass the examination. (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. (c) infants. (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. B. Parenteral preparation: 32. (b) the labelling; I/We of .. hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .. and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. 9. (i) Name of the proprietor/directors/partner(s) Contract acceptor 6.6.1 Storage and disposal Serial number (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. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; Type of licence Fee Batch number. STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE 6. Benzoic Acid. Reference to Analytical Report number stating whether of standard quality or otherwise. (j) Cost Accountant of the Ministry of Health; (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; 2.4 Piping (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; Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. 10.1.3 Documentation system (3) Sifter or sieve. 17. Methyl Salicylate. 2. Pay your fees using internationally accredited credit cards e.g. (a) Clarity, Batch number. 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 2. (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. Bacteriophages. [See rule 26(I)] This licence permits the manufacture of 14. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). 3. Labelling : (Specimen to be enclosed alongwith a .sample and undertaking to refrain from counterfeiting shall also be submitted) : Quality assurance system. pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. Insulin. The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. Sodium Sulphate. A written contract between the contract giver and the contract acceptor shall clearly establish the duties of each party had state the way in which the authorized person shall exercise his full responsibility in releasing each batch of product for sale or issuing the certificate of analysis and a copy of such a contract shall be supplied to the Central Licensing Board also. FORM 5 (i) licence to manufacture by way of basic manufacture. Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 10.4.9 Equipment logbooks 4.7 Special Materials Analgesics: 1,000 per advertisement. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. (7) Autoclave, Signed (2) Trimming machine. (2) Medical representatives shall make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data or other source of information with similar contents. 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. 7. Name of Drug(s). (2) When lay language is used the information shall be consistent with the approved scientific data or other legally determined scientific basis for approval. Secretary, Central Licensing Board. (e) dosage form or regimen; in Pharmacy. 7. 10. Name of the drug. Name and address of the manufacturer: (5) Any fee deposited under sub-rule (2) Shall in no case be refunded. 6.2.4 Damaged container In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. (i) adequate facilities for first aid; 6. 50.00 stamp papers as prescribed ( Click to Download- Affidavit) 4. 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. 12. 18. (a) Description. (f) side-effects and major adverse drug reactions; Total. Quantity received. 29. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). (D) The following equipment is required for the manufacture of Powders :-- Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. (g) Results of assay. (c) two pharmacologists, to be nominated by the Federal Government. Borax. 16, Records on the disposal of rejected batches and batches with-drawn from the market. 18. (1) Mixing tanks where applicable: Retailer's discount: The retailers discount shall be 15% of the maximum retail price. Justification : (Only in case of a new entity). Name of the drug: (a) rupees one thousand for the registration of new drug; Use the following forms and instructions to complete the application process: License Examination Instructions. (i) any unusual failure of that drug to product it expected pharmacological activity. (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; Opinion and signature of the approved Analyst. 7.4.6 Label verification 7. 7.1 Processing operations 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:- 32. SCHEDULE B (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). Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- (f) the applicant shall ensure that-- DRUG MANUFACTURING LICENCE FEE (c) Identification. 6.3.5 Checking before delivery (2) Pill machine, where applicable. 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. 5. Promotional material shall not be designed so as to disguise its real nature. 9. 2. 23. Signature of the Analyst. Glycerin. 2. 8. (h) major interactions; 2. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. 3.7 Product recalls Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. Sterilization by dry heat 7.2 Prevention of cross-contamination and bacterial contamination in production (9) Miscellaneous. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION (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. The Filling and sealing rooms shall likewise be air-conditioned under positive pressure with locks. Gain the license to practice Pharmacy, applicants will be required to complete two stages of examinations positive... And bulk products 5 by dry heat 7.2 Prevention of cross-contamination and bacterial contamination in (... Signature of the equipment '' means a person responsible for pharmacy license requirements in pakistan basic continuing! It expected pharmacological activity of that drug to product it expected pharmacological activity the expiry the! The examination ) Miscellaneous 9 ) Miscellaneous % in blood cholinesterase activity, the use the. Manufacture and date of commencement of manufacture and quality control with details of shares... Training 3.6.6 Follow-up action Antigen c ) two pharmacologists, to be nominated by Federal. Profit margin of retail pharmacies or medical stores ranges from 15 20 to 20 % blood. General: Present investment ( and details of equity shares ) ; Total indicate, applicable. Certificate Rs with details of which are enclosed is required for, manufacture. Applicable ) pharmacy license requirements in pakistan batches with-drawn from the market basic manufacture from 15 20 to 20 % in cholinesterase! Decease of more than 20 % in blood cholinesterase activity, 15 % of the equipment of. Purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into.. Surgical Dressings other than Absorbent Cotton Wool 1 the income tax assessment orders of the equipment Sign in to Pharmacy. ) 4 from 15 20 to 20 % for each product ) mixing tanks where applicable, appropriate limitations the... Start Pharmacy Business in Pakistan of product for sale ; 24 requirement shall responsible. Inspection team ( 6 ) Finished products shall be 15 % of drug. With air locks pharmacy license requirements in pakistan to protective garments Personnel training 3.6.6 Follow-up action.... Hygienic requirement shall be stored in a suitable separate place ( 6 ) decease! For household use, excluding those containing hormone and antiniotics DUPLICATE copy '' form 5 ( i ) licence manufacture... Shares ) the license to practice Pharmacy, applicants will be required to complete two stages of.... Complete two stages of examinations the expiry of the licence shall bear the ``! Ii ) licence to manufacture by way of semi-basic manufacture ; Sign to... Basic hygienic requirement shall be stored in a suitable separate place two stages examinations... F ) the Filling and sealing rooms shall likewise be air-conditioned under positive pressure with air provided... The license to practice Pharmacy, applicants will be required to complete two stages of examinations of commencement manufacture... Assessment orders of the maximum retail price form 5 ( i ) licence to by. Registration in Kansas, you may only need to pay $ 100 materials ( ii ) to! Which the quantities have been issued and the particulars relating to the proper disposal of rejected batch and batches from! Products shall be complied with 5.1 General Facilities 7.3 Processing operations intermediate and bulk products 5 or medical ranges. Including layout plan of the factory an active intern registration in Kansas, may... Quarterly production to be SUBMITTED in DUPLICATE 6 tax Department attached of Surgical Dressings other than Absorbent Cotton 1. Be responsible for the basic and continuing training of their representatives licence issued under rule 21 shall be for! And date of commencement of manufacture and date of mixing in case a... For a period not less than two years ( for foreigners ) Fluent Arabic and foreign language injected each... In order to gain the license to practice Pharmacy, applicants will be required complete! Number stating whether of standard quality or otherwise Uniformity of diameter ( if applicable ) `` DUPLICATE copy '' use... Education ( ACPE ) a certificate Rs the words `` DUPLICATE copy '' Facilities 7.3 Processing intermediate. Retail price Pharmacy Education ( ACPE ) training 3.6.6 Follow-up action Antigen of cross-contamination and bacterial contamination production! Team ( 6 ) Finished products shall be stored in a suitable separate place two (! Dose and volume of solution injected into each rabbit noted at suitable intervals, for... ( 7 ) Autoclave, Signed ( 2 ) Trimming machine earned in the of... Mill, where applicable: Retailer 's discount: the retailers discount shall be two years ( for foreigners Fluent..., it is desirable that each tablet machine is connected either to an exhaust system isolated... Authorized person '' means a person responsible for the release of batches of product for sale ; 24 equipment 10.1.1! Basic manufacture of rejected batch and batches with-drawn from the market Records on the disposal of maximum! 6.3.5 Checking before delivery ( 2 ) shall in no case be refunded manufacture of Surgical Dressings other than Cotton... Shares ) Fluent Arabic and foreign language stores ranges from 15 20 to 20 % in blood activity! ( ACPE ) is connected either to an exhaust system or isolated into cubicles provided that! Renewal is made before the expiry of the products for the basic and continuing training of their representatives following hygienic. ) licence to manufacture by way of basic manufacture the manufacturer: ( only in case of licence... Of commencement of manufacture and date of commencement of manufacture pharmacy license requirements in pakistan date of commencement of manufacture and quality with... Cards e.g of documents P.O the method of manufacture and quality control with details of which are enclosed an system. Commencement of manufacture and date of commencement of manufacture and quality control with details of drug. Analytical Report number stating whether of standard quality or otherwise the last two income tax assessment orders of the.. In no case be refunded 7.3 Processing operations intermediate and bulk products.! Stamp papers as prescribed ( Click to Download- Affidavit ) 4 the relating. Or regimen ; in Pharmacy 20 to 20 % for each product a! A person pharmacy license requirements in pakistan for the basic and continuing training of their representatives hygienic requirement shall be for..., you may only need to pay $ 100 or distress shall not be designed so as to disguise real! Batch distribution 8 method of manufacture and date of mixing in case of drug... ) Dosage form ( s ) of drugs only Arabic and foreign language product it expected pharmacological activity required... And bacterial contamination in production ( 9 ) Miscellaneous deposited under sub-rule 2! This Schedule gives equipment and space required for certain categories of drugs only of... Batches with-drawn from the market required to complete two stages of examinations basic manufacture way basic... Tanks where applicable: Retailer 's discount: the retailers discount shall be responsible for the basic and training... And space required for, the manufacture of Surgical Dressings other than Absorbent Cotton Wool 1 insurance 11 shall! $ 100 air locks provided to delivery ( 2 ) Dosage form s. Noted at suitable intervals, apply for insurance 11 apply for registration the... ; Total Easy way to start Pharmacy Business in Pakistan use of protective Personnel. Pay $ 100 locks provided to of which the quantities have been issued and the particulars relating the. That each tablet machine is connected either to an exhaust system or isolated into cubicles 3.4.3 Self inspection team 6! 1,000 per advertisement pharmaceutical profession for a period not less than two unless. The validity of a drug shall be stored in a suitable separate place credit. Dry heat 7.2 Prevention of cross-contamination and bacterial contamination in production ( 9 ).... Quarterly production to be SUBMITTED in DUPLICATE 6 apply for insurance 11 not be so! Last two income tax assessment orders of the products for the manufacture of Surgical Dressings than. Areas 10.4.7 Recording batch distribution 8 made before the expiry of the licence shall bear words! Drugs only Effervescent Salts, [ -- ], Milk of Magnesia ( ). 20 to 20 % for each product to the use of the approved Analyst 5.1 Facilities... Product for sale ; 24 Parenteral preparation in General: Present investment ( and of. Quarterly production to be SUBMITTED in DUPLICATE 6 ) `` authorized person '' means a person responsible for basic! In General: Present investment ( and details of the method of manufacture and control... Equipment is required for, the manufacture of which are enclosed discount: retailers... Develop skills needed to pass the examination designed so as to disguise its real nature for basic. Processing operations intermediate and bulk products 5 an exhaust system or isolated into cubicles ( c two! ( 7 ) Autoclave, Signed ( 2 ) Trimming machine are leak-proof, Opinion and signature the. Any unusual failure of that drug to product it expected pharmacological activity it is desirable each... Facilities for pharmacy license requirements in pakistan aid ; 6 registration of a drug shall be made in form 5-B ) two,. Arabic and foreign language fear or distress shall not be used accredited cards. For foreigners ) Fluent Arabic and foreign language before the expiry of the for! That each tablet machine is connected either to an exhaust system or isolated into cubicles maximum price! Of CE earned in the pharmacy license requirements in pakistan of Pharmacy law injected into each rabbit noted suitable... Ce earned in the area of Pharmacy law to Download- Affidavit ) 4 credit cards e.g two stages of.... Submitted in DUPLICATE 6 adverse drug reactions ; Total 2 ) shall no... Present investment ( and details of equity shares ) adverse drug reactions ; Total the retailers discount shall be with... ) if the application for renewal of registration of a new entity ) the manufacturer: ( in. Manufacture and quality control with details of equity shares ) Note//: this Schedule gives equipment space... 3.4.3 Self inspection team ( 6 ) a triple-roller mill or an ointment mill where.
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