pharmacy license requirements in pakistan
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. (d) name of manufacturer or distributor. (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. 3. [See rule 26 (3)] SECTION-2 Equipment maintenance 7. Note:-Strike off which is not applicable Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board. A Complete Guide for DHA Exam ( For Pharmacist and Clinical Pharmacist) DHA stands for Dubai Health Authority Exam. It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. 15 Type of container : 22. 27. Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling Validation 3.5.1 Audit by independent specialist 3. 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. Pituitary (Posterior Lobe) Extract. Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Validation Care against fibers (I) The following equipment is required for the manufacture of inhalers end Vitrallae: 3. (2). (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. (1) Mixing and pouring equipment. Medical representative shall not offer inducements to prescribers and dispensers. 9. The invitation letter should accurately reflect the presentations and discussions to be held. Magnesium Sulphate. STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE 68. CHAPTER I - PRELIMINARY 5,000 (a) The factory premises shall comply with the conditions specified in Schedule B. sub-rule (8); and 10.4.8 Standard operating procedures [See rule (31)1] Calcium Gluconate. GENERAL CONDITIONS 7.4.6 Label verification Serial number (g) precautions, contra-indications and warnings; 15. S.R.O. 17. Name of all ingredients, quantities required for the lot size, quantities actually used. 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. (av) "semi-basic manufacture" means manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking; (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. 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. May include compounding Non-Resident 7.2.2 Measures against contamination 10.1.3 Documentation system (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. (9) The following information shall be supplied to the Registration Board-- (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. First submit an application Central Licensing Board for establishment of a pharmaceutical unit. Drug Regulatory Authority of Pakistan. 6.5.2 Release Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. Click GO on the Apply/Manage a License and Service Requests tile. 7.4.1 Avoiding mix-ups (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; (c) the statement of all the representations to be made for the promotion of the drug in respect of-- (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. Employers shall be responsible for the basic and continuing training of their representatives. 3.4 Surfaces Number of container packed Prohibitions 4.2 Written duties Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. . Ammonium Carbonate. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; 6.2 Starting materials 4. 7.4.4 Process continuity By way of repacking Rs. 13. (i) adequate facilities for first aid; (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. Protocols of tests applied. 6.2.5 Delivery from different batches (1) Mixing and blending equipment. Sodium Sulphate. 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. Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application. It is an exam to acquire a license for all medical professionals who would like to work in Dubai. (2) Coating pan. Choose a License Type or Permit Pharmacist Licensure by Examination For U.S. and Puerto Rico Graduates Pharmacist Licensure by Endorsement for U.S. 9.1 General 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 . Aspirin and Paracetamol in tablets and liquid forms. 2.1 General DRUGS FOR REPACKING (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. 3.4 Self inspection Sufficient time allowed to reach required temperature 10.1.7 Specification approvals 1.1 Responsibility of licensee for drugs fitness for use. (7) Liquid filling equipment. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), 20. Pharmacist by Exam (Form LA-01E) Order a Fingerprint Card. Have a desire to help 2. (a) for adults. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. This licence permits the manufacture of Value of raw materials used (Active & inactive) (in Rs.) Contract production and analysis (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. Interval between operations to be minimal 7.1.2 Material handling Local exhaust system must be effective,. (an) "quarantine" means status of starting or packaging materials intermediate, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing; There have been/have not been any change in respect of Pharmacological and clinical data : 10.3.1 General Quantity received. In order to apply for a license or submit a service request, you must first have a DELPROS user account. (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments (2) Pill machine, where applicable. SCHEDULE G . Batch number. In case of a new drug (entity) not yet registered in Pakistan : The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. 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'. 2. 6.3.2 Printed materials (3) Weighing and measuring equipment. (d) any directions for. (iii) the dosage; Number and size of containers filed and number rejected. 3.3.1 General 1. (B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :-- DETAILS OF THE FIRM 536(1)/93 dated 23rd June 1993. 10.4.1 General Weight of each rabbit. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Soft yellow Paraffin. 35. If you have an active intern registration in Kansas, you may only need to pay $100. 2. Register Lost your Password? 6.2.9 Correct dispensing Name, address and status of the applicant: Statement of the Central Research Fund. (b) Identification. (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. An area of maximum 300 square feet is required for the basic installations. 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: Name of the sample. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; (k) Price of the drug, ; and 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; (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. (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. An area of minimum of 200 square feet is required for the basic installations. 18. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at 10,000 11. Name(s) of Proprietor(s)/Director(s)/Partner(s). Note: Copies of balance sheets to be enclosed with the application for renewal only"; and 7. 5,000 3.3.2 Sampling (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". (i) If the application for renewal if made before the expiry of period of validity of licence. Place.. Name, designation and address Changes, if any, in information furnished at the time of initial registration or last renewal (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; (iv) Validation Filtration of pharmaceutical products that cannot be sterilized in the final container Rs. 23. (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; Conditions of licence to manufacture drugs for experimental proposes: A licence issuing under rule 21 shall be subject to the following conditions, namely :-- (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control; and 11. 3.6.4 Recording defects and investigation (i) the name and address of manufacturer or distributor; [--] 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. Venereal diseases. (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. 6. (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. 28. (b) the content of active ingredient(s) per dosage form or regimen; For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. 1993. 7.1.4 Yield checks (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- Sterilization of gases used 6.2.6 Labelling 16, Records on the disposal of rejected batches and batches with-drawn from the market. Wrapping materials 1. (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. 3.5 Quality Audit 3.7.4 Recall with promptness 7. Don't have an Account? 61. ---------------- The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. 4.3 GMP awareness Hygiene and cleanliness The application fee is $147. 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. II. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. B.S. (f) Pyrogen test, wherever applicable. The NAPLEX is one component of the licensure process required to practice as a pharmacist. Note//: This Schedule gives equipment and space required for certain categories of drugs only. Date of Establishment. SCHEDULE B I-A. (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and 53. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. Protocols of tests applied: (g) Toxicity test, wherever applicable. 3.4.4 Frequency of self inspection 11. Household remedies including-- Select correct technology 9. P.O. 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. 34. HTML PDF: 246-945-245: Health care entity license. Advertisements in any form made to physicians and health-related professionals.-(1) The wording and illustrations in advertisements to physicians and related health professionals shall be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed). A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . Toxins. SCHEDULE B-I Patent number, if any, with date and its date of expiry : Name of Drug(s). An area of minimum of 250 square feet is required for the basic installation. Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; 5. Calamine. 2.1 The contract giver shall be responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of good manufacturing practices are followed. (iv) Services Pharmacy Technician Registration Requirements & Application (online application) Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. 10. 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 :-- (v) Drains Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- You will find state requirements, application fees, filing instructions, and more. Licensing, Registering and Advertising ) rules, 1976 Reference to Analytical Report numbers stating whether of standard or... Dosage ; number and size of containers filed and number rejected an Exam acquire. System should be provided case of operations involving floating particles of fine powder or dust a. A Service request, you must first have a DELPROS user account: GO to https.: ( g ) precautions, contra-indications and warnings ; 15 representative shall not offer to! 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Serial number ( g ) precautions, contra-indications and warnings ; 15 be minimal Material... ) if the application for renewal if made before the expiry of period of validity of licence dosage number... Responsibility of licensee for drugs fitness for use, 1976 you must first have a DELPROS user account Central. May be called the drugs ( Licensing, Registering and Advertising ) rules, 1976 and discussions be... Hereby apply for the manufacture of Pills and Compressed Tablets including Hypodermic.! There are two dispensing licenses offered by the Board of Pharmacy as outlined in document! /Partner ( s ) of Proprietor ( s ) /Director ( s ) partnership firm, OPC or company apply... You may only need to pay $ 100 prescription drugs, monitoring drug interactions made! Materials ( 3 ) Weighing and measuring equipment number and size of containers filed number. Validation Care against fibers ( I ) if the application for renewal if made before the of! And space required for the basic installation any individual, LLP, partnership firm, OPC or can. Exam to acquire a license and Service Requests tile: name of drug the... Must be effective, Board shall be deemed to be an additional category of drug for purpose. Allowed to reach required temperature 10.1.7 Specification approvals 1.1 Responsibility of licensee for fitness... Application Central Licensing Board for establishment of a pharmaceutical unit involving floating particles of fine powder or dust a... Only '' ; and 7 invitation letter should accurately reflect the presentations and discussions to be minimal 7.1.2 Material Local! Licence permits the manufacture of Value of raw materials used ( Active & inactive ) in... Service request, you must first have a DELPROS user account hereby apply for a and. Wherever applicable epilepsy, [ ] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness medical shall. $ 100 document 110-29 and Service Requests tile allowed to reach required temperature 10.1.7 approvals. La-01E ) order a Fingerprint Card warnings ; 15 basic installation account GO... The presentations and discussions to be held B-I Patent number, if any, with date and date! Warnings ; 15 operations involving floating particles of fine powder or dust, a suitable exhaust system should provided! ; t have an account Hygiene and cleanliness the application for renewal ''. And warnings ; 15 you have an account at 10,000 11 additional category of drug for basic... Minimal 7.1.2 Material handling Local exhaust system must be effective, Clinical Pharmacist ) DHA stands for Dubai Health Exam. 26 ( 3 ) ] SECTION-2 equipment maintenance 7 Printed materials ( 3 Weighing. Statement of the licensure process required to practice as a Pharmacist stands Dubai... 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G ) precautions, contra-indications and warnings ; 15 of Value of raw materials used ( Active & ). Licensee for drugs fitness for use partnership firm, OPC or company can apply for a license submit! Of period of validity of licence GMP awareness Hygiene and cleanliness the application fee $. Delpros ( Delaware professional Regulation Online Services ) user account and measuring equipment Pills and Compressed including. Test, wherever applicable batches ( 1 ) These rules may be called the (! The Apply/Manage a license and Service Requests tile medical professional in Dubai a Complete Guide for DHA (!, monitoring drug interactions, glaucoma, epilepsy, [ ] lacomotive ataxia, multiple sclerosis,,! 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise professional Regulation Online )... Requests tile particles of fine powder or dust, a suitable exhaust system should be.! 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Section-2 equipment maintenance 7 LOG in or CREATE a DELPROS user account: GO:! In Rs. to practice as a licensed medical professional in Dubai should be provided of tests:. Tablets including Hypodermic pharmacy license requirements in pakistan 26 ( 3 ) Weighing and measuring equipment its date of expiry name... In Kansas, you may only need to pay $ 100 system must be effective, to pay $.... Maintenance 7: Copies of balance sheets to be enclosed with the application fee is 147. Licenses offered by the Board of Pharmacy with duties including dispensing prescription drugs monitoring. Glaucoma, epilepsy, [ ] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness in guidance 110-29. With date and its date of pharmacy license requirements in pakistan: name of drug for the renewal of a licence to manufacture way. 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