Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

AUDIENCE: Emergency Medicine, Pediatrics

ISSUE: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

BACKGROUND: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and other health care providers to measure exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. See the recall notice for affected models and lots.

RECOMMENDATION: Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Class I Recall Notice and press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258133.htm

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

AUDIENCE: Emergency Medicine, Pediatrics

ISSUE: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

BACKGROUND: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and other health care providers to measure exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. See the recall notice for affected models and lots.

RECOMMENDATION: Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Class I Recall Notice and press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258133.htm

What's New on the FDA Drugs Site

June 7, 2011

BPCA/Pediatric Exclusivity Statistics
Pediatric Exclusivity Granted (updated)
Pediatric Exclusivity Statistics (updated)
Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
MedWatch Safety Alert: American Regent Injectable Products: Recall - Visible Particulates in Products (updated)
National Drug Code Directory (updated)
NDC Product File Definitions (updated)
NDC Package File Definitions (updated)
June 6, 2011

Guidance for Industry: Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB)
New and Generic Drug Approvals

June 7, 2011

Avalide (hydrochlorothiazide and irbesartan) Tablets, Sanofi-Aventis, Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision
Corgard (nadolol) Tablets, King Pharmaceuticals Inc., Labeling Revision
Corzide (bendroflumethiazide and nadolol) Tablets, Pfizer, Inc., Labeling Revision
Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
Losartan Potassium Tablets, Huahai US Inc., Approval
Macrobid (nitrofurantoin and macrocrystaline) Capsules, Almatica Pharma, Inc., Labeling Revision
Macrodantin (nitrofurantoin macrocrystals) Capsules, Almatica Pharma, Inc., Labeling Revision
Twynsta (amlodipine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Approval
Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Approval
Zolpidem Tartrate Extended-Release Tablets, Actavis South Atlantic LLC, Approval
Zolpidem Tartrate Extended-Release Tablets, Synthon Pharmaceuticals, Inc., Approval
June 6, 2011

Diovan (valsartan) Tablets, Novartis, Labeling Revision
Letrozole Tablets, Synthon Pharmaceuticals, Inc., Approval
Letrozole Tablets, Fresenius Kabi Oncology, Approval
Letrozole Tablets, Endo Pharmaceuticals, Inc., Approval
Letrozole Tablets, Dr. Reddy’s Laboratories Ltd., Approval
Letrozole Tablets, Roxane Laboratories, Inc., Approval
Letrozole Tablets, Natco Pharma Ltd., Approval
Letrozole Tablets, Accord Healthcare, Inc., Approval
Letrozole Tablets, Impax Laboratories, Inc., Approval
Letrozole Tablets, Sun Pharmaceutical Industries Ltd., Approval
Letrozole Tablets, Kudco Ireland Ltd., Approval
Letrozole Tablets, TEVA Pharmaceuticals, Approval

What's New on the FDA Drugs Site

June 3, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
Drug Shortages: Current Drug Shortages: Foscarnet Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
Drug Shortages: Current Drug Shortages: Intravenous Fat Emulsion (updated)
Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
Drug Shortages: Current Drug Shortages: Metoclopramide injection (updated)
Drug Shortages: Current Drug Shortages: Multi-Vitamin Infusion (Adult and pediatric) (updated)
Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 23.4% (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Phosphate Injection (updated)
Drug Shortages: Current Drug Shortages: Tromethamine (updated)
Drug Shortages: Current Drug Shortages: Vecuronium Injection(updated)
Drug Shortages: Current Drug Shortages: Vincristine Sulfate Injection(updated)
MedWatch Safety Alert: Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
Office of Translational Sciences (updated)
New and Generic Drug Approvals

June 3, 2011

Banzel (rufinamide) Oral Tablets, Eisai, Inc., Labeling Revision
Banzel (rufinamide) Oral Suspension, Eisai, Inc., Labeling Revision
Clindamycin Hydrochloride Capsules, Matrix Laboratories Ltd., Approval
Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Donepezil Hydrochloride Tablets, Apotex Inc., Approval
Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals, Labeling Revision
Exforge HCT (amlodipine besylate, hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision
Prevacid (lansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals, Labeling Revision
Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, Takeda Pharmaceuticals, Labeling Revision
Retisert (fluocinolone acetonide) Implant, Bausch & Lomb, Inc., Manufacturing Change or Addition
Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals, Inc., Approval
Venlafaxine Hydrochloride Extended-Release Capsules, Torrent Pharmaceuticals Ltd., Approval
Tussionex Pennkinetic (chlorpheniramine polistirex and hydrocodone polistirex) Extended-Release Oral Suspension, UCB, Inc., Approval

Uppsala Monitoring Centre Newsletter Issue nr 2, June - 2011

The second quarter of 2011 is here and the Uppsala Monitoring Centre’s new Drug Dictionary China will be launched, the upcoming WHO Drug Dictionary User Group Meeting will take place in Brussels, the UMC continues to develop new SDGs and lastly we would like to inform you about the Japanese Cross Reference Tool.


The New Drug Dictionary China – The Code to China

It is now here. The new Drug Dictionary China, which translates Chinese character medicinal product names into the WHO DDE global coding system. This conversion gives you direct access to a collection of up-to-date medicinal product information and analytical tools which is contained within the WHO DDE for drugs used in China; it also includes Traditional Chinese Medicines.
A world premiere for the new Drug Dictionary China is going to be held at the 47th DIA Annual meeting in Chicago, IL on June 19-23, 2011.
Come and meet us in Chicago!
Read more about the new Drug Dictionary China www.CodetoChina.com


The WHO Drug Dictionary User Group Meeting in Europe Brussels

The WHO Drug Dictionary User Group Meeting in Europe will take place in Brussels, on September 15th, 2011.
At the 2010 User Group meetings the groups talked about how the dictionary is used in everyday work – how this can be used as input to the developers of coding software and how we can develop
‘Best Practices’ based on these discussions. Best Practices have now been published as drafts and more are underway. At the User Group meeting in Brussels we will – among other things – develop these practices further with the coded data in mind; from the preparation of a clinical trial to the data collection and coding, data storage, analysis and interpretation.
Sign up at the User Group Portal to take part of what's new and ongoing in the WHO Drug Dictionaries.
Contact us at drugdictionary@umc-products.com to let us know if there are any speakers or topics that you would like to be present at the meeting.


Standardised Drug Groupings (SDGs) – Continues to Develop

In 2010 the first Standardised Drug Groupings were launched – additional classifications and lists that can be used in the preparation of Medication of Interest lists and for the analysis of coded data.
The work continues in 2011 – a new working group will put together new groupings, which will be prioritized and developed.
Please, let us know if you would like to suggest a new SDG or if you want to learn more about the SDGs. We welcome old as well as new members in the SDG Working Group.
Contact us at drugdictionary@umc-products.com if you want to participate – or if you want to know more about how the group is going to develop the new groupings.


Launch of the Japanese Cross Reference Tool

The UMC has together with ‘Ijoken’ - the maintenance organization Iyakuhinmey Data File (IDF) in Japan – created a Cross Reference Tool that will make it easy to find the WHO Drug Dictionary Enhanced code that corresponds to a selected code in the IDF dictionary (in Japanese). This will make it easy and possible to analyze IDF-coded data with the tools included in the WHO Drug Dictionary Enhanced. This tool is now being tested by few Japanese pharmaceutical companies and it will be launched in June, 2011.

EDQM News - June 2011

EDQM
World Blood Donor Day – Celebrating the gift of blood
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html

European Pharmacopoeia
Annual meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia took place in Madrid on 9 to 10 May 2011. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

IMPORTANT: Rapid implementation of revised general chapter 5.2.8
The revised general chapter 5.2.8 Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products has been adopted following a fast-track procedure and is to be implemented on 1 July 2011. More information: http://www.edqm.eu/en/News-and-General-Information-43.html

HealthCare – Blood Transfusion
2007 and 2008 Reports on the Collection, Testing and Use of Blood and Blood Components in Europe are now available to download: http://www.edqm.eu/en/Reports-70.html

Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html

Control of Medicines
European Network of Official Medicines Control Laboratories held its 16th Annual Meeting in Düsseldorf, Germany, from 23-27 May 2011.
More information: http://www.edqm.eu/en/News-and-General-Information-612.html

Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order.
NEW : ONLINE VERSION ALSO AVAILABLE. In order to be able to access the online version of this publication, you will need to register your print copy at : www.edqm.eu/register, using the EPID code attached at the back of the guide. Online registration gives users access to the guide in all the available languages.
More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html

Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Employment
Vacancy Notice N° e128/2011: Scientific Programme Officer (Grade A1/A2), Laboratory Department (Dlab) - Analytical Chemistry Division
Vacancy Notice N° e129/2011: Scientific Programme Officer (Grade A1/A2), Division Certification of Substances
Vacancy Notice N° e130/2011: Program Officer (Scientific) (Grade A1/A2), Division Certification of Substances
Closing date for all vacancies: 23 June 2011

Vacancy Notice N° e137/2011: Proofreader (Grade B3), European Pharmacopoeia Department (EPD) - Translation Unit

Closing date: 24 June 2011

Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html

Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html

Other interesting events supported by the EDQM:
APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html

FDA MedWATCH

Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed

[UPDATED 06/02/2011] FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm

Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication

[Posted 06/02/2011]

AUDIENCE: Consumers, Patients

ISSUE: FDA notified consumers, women who participate in breast cancer screening and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Thermographic systems use an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms.

BACKGROUND: Certain facilities, websites, and mobile units are promoting the use of thermography as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming that is a substitute for or superior to mammography. They also claim that thermography can detect pre-cancerous abnormalities and diagnose breast cancer long before mammography and that compressing the breast during mammography will cause or spread cancer by pushing cancer cells into additional locations in the body.

RECOMMENDATION: Woman should have regular mammograms according to screening guidelines or as recommended by a health care provider. Patients should follow a health care provider's recommendations for additional breast diagnostic procedure which could include thermography, clinical breast exam, breast ultrasound, MRI or biopsy.

Read the MedWatch safety alert, including links to the FDA Safety Communication, News Release, Consumer Update and other resources at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257707.htm
Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products


AUDIENCE: Pharmacy, Risk Manager

ISSUE: FDA and Aidapak Services notified healthcare professionals and hospital pharmacies of a nationwide recall of multiple repackaged drug products after learning of the potential cross contamination of non-penicillin drug products that were repackaged in the same facility. There is the potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products that could result from using these recalled products.

BACKGROUND: Please click on the link in the firm press release to view a complete listing of products affected by this recall. All products affected by this recall are stamped with Aidapak's packaging stamp.

RECOMMENDATION: Hospitals, Emergency rooms, clinics and other healthcare facilities should stop distributing these products immediately and quarantine the products, and then contact Aidapak Services for return instructions.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257723.htm

FDA MedWatch

Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

AUDIENCE: OBGYN, Family Practice, Patient

ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available. Read the drug safety communication for more information on these studies.


BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.


RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication and Questions and Answers, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm

What's New on the FDA Drugs Site

June 1, 2011

FDA Drug Safety Podcast for Healthcare Professionals: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
Manual of Policies and Procedures (MAPPs) Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups (PDF - 119KB)
National Drug Code Directory (updated)
New and Generic Drug Approvals

June 1, 2011

Donepezil Hydrochloride Tablets, Matrix Laboratories Ltd., Approval
Donepezil Hydrochloride Tablets, Cipla Ltd., Approval
Donepezil Hydrochloride Tablets, Wockhardt Ltd., Approval
Donepezil Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
Donepezil Hydrochloride Tablets, Sandoz Inc., Approval
Donepezil Hydrochloride Tablets, Sun Pharmaceutical Industries Ltd., Approval
Donepezil Hydrochloride Tablets, Huahai US Inc., Approval
Donepezil Hydrochloride Tablets, Hikma Pharmaceuticals, Approval
Donepezil Hydrochloride Tablets, Actavis Pharma, Approval
Donepezil Hydrochloride Tablets, Torrent Pharmaceuticals Ltd., Approval
Donepezil Hydrochloride Tablets, Pliva Hrvatska, Approval
Donepezil Hydrochloride Tablets, Jubilant Life Sciences Ltd., Approval
Donepezil Hydrochloride Tablets, Teva Pharmaceuticals, Approval
Donepezil Hydrochloride Tablets, Dr. Reddy’s Laboratories Ltd., Approval
Donepezil Hydrochloride Tablets, Aurobindo Pharma, Approval

ANMAT

http://www.anmat.gov.ar/webanmat/Legislacion/Medicamentos/disp_3686-2011.pdf

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
PRODUCTOS MEDICINALES
Disposición 3686/2011
Establécense los Requisitos mínimos para solicitar la condición de venta
libre de una especialidad medicinal.

ANMAT TRAZABILIDAD

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
ESPECIALIDADES MEDICINALES
Disposición 3683/2011
Sistema de Trazabilidad de medicamentos que deberán implementar las
personas físicas o jurídicas que intervengan en la cadena de
comercialización, distribución y dispensación de especialidades
medicinales incluidas en el Registro de Especialidades Medicinales.